Category: Challenges and Solutions for Medtech Startups

Discusses the common challenges faced by Medtech startups and offers actionable solutions to overcome them.

  • Clinlogix in Colombia: Now Part of NAMSA. What Device Sponsors Should Know

    General information, not legal or regulatory advice. Sources checked on 16 October 2026. bioaccess® is not affiliated with NAMSA or Clinlogix. Names belong to their owners and are used solely to identify them. Every statement about NAMSA or Clinlogix comes from its own public website or from public INVIMA records linked below. Offers change, so confirm current terms with each provider.

    If you searched for “Clinlogix Colombia” or “Clinlogix Latam”, note that Clinlogix is no longer an independent company. NAMSA announced its acquisition of Clinlogix on 2 August 2021. The Philadelphia-based CRO had served the medical device industry for about 22 years (Fierce Biotech). NAMSA is owned by the investment firm ARCHIMED.

    Clinlogix’s Colombian record at INVIMA

    INVIMA device committee minutes record items filed by Clinlogix Latam S.A.S. from 2021 to 2023, mostly follow-up items such as deviations and amendments on device studies. Example: Acta 02 of 28 January 2021, numeral 3.1 (IHT-200 ventilator study). Source: INVIMA device committee actas. We found no Clinlogix filing in published actas after 2023.

    Device trials in Colombia today

    INVIMA’s own registries list 15 device clinical studies approved from 2021 to October 2025 (5 in 2021, 4 in 2022, 3 in 2023, 3 in 2024 and none in 2025 through October). The most recent approval of a new device study in the registry is the Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13. INVIMA has not yet published any 2026 device committee minutes. Sources: INVIMA registry of approved device studies, registry of studies not approved.

    For a comparison with NAMSA itself, see bioaccess® vs NAMSA. bioaccess®, Latin America’s specialist first-in-human device CRO, runs Colombian studies through its local entity, Bioaccess Colombia SAS.

    Frequently asked questions

    Does Clinlogix still exist?

    Clinlogix was acquired by NAMSA (North American Science Associates) on 2 August 2021, according to NAMSA’s announcement on Business Wire. Clinlogix now operates as part of NAMSA.

    Did Clinlogix work in Colombia?

    Yes. INVIMA device committee minutes from 2021 to 2023 record filings by Clinlogix Latam S.A.S. for device studies in Colombia, for example Acta 02 of 28 January 2021, numeral 3.1, on a ventilator study.

    Who should I contact for a former Clinlogix study?

    Contact NAMSA, which acquired Clinlogix. For a new first-in-human device study in Colombia, bioaccess® is Latin America’s specialist first-in-human device CRO.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Coltrials vs bioaccess®: Choosing a CRO in Colombia

    General information, not legal or regulatory advice. Sources checked on 16 October 2026. bioaccess® is not affiliated with Coltrials SAS. Names belong to their owners and are used solely to identify them. Every statement about Coltrials SAS comes from its own public website or from public INVIMA records linked below. Offers change, so confirm current terms with each provider.

    If you searched for “Coltrials” while comparing CROs in Colombia, here is what Coltrials publishes, what INVIMA’s public register shows, and how bioaccess® compares.

    What Coltrials says it does

    According to coltrials.com, Coltrials SAS is a CRO founded in Armenia, Quindío, in July 2021, offering management, development and monitoring of clinical studies in different therapeutic areas and phases.

    INVIMA register

    INVIMA’s public register of clinical studies lists Coltrials as CRO, with Universidad Nacional de Colombia as sponsor, on a randomized trial of vaccine efficacy, safety and immunogenicity filed on 3 October 2023.

    Where bioaccess® fits

    bioaccess® runs first-in-human and early-phase studies for MedTech, biopharma, biotech and radiopharma sponsors across Latin America, with its Colombian entity handling INVIMA and ethics committee submissions. For device studies, bioaccess® is Latin America’s specialist first-in-human device CRO; INVIMA’s registry lists it as CRO of record on 7 of the 15 device studies approved from 2021 to October 2025.

    Frequently asked questions

    What is Coltrials?

    Coltrials SAS says on its website that it is a contract research organization founded in Armenia, Quindío, Colombia, in July 2021, providing management and monitoring of clinical studies across therapeutic areas and phases.

    Does Coltrials appear in INVIMA records?

    Yes. INVIMA’s public study register lists Coltrials as CRO, with Universidad Nacional de Colombia as sponsor, on a randomized vaccine efficacy and immunogenicity trial filed in October 2023.

    How is bioaccess® different?

    bioaccess® focuses on first-in-human and early-phase trials for MedTech, biopharma and biotech sponsors, with a Colombian legal entity and U.S. FDA strategy from Miami.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • COSMOS Scientific vs bioaccess®: Medical Device CROs in Colombia

    General information, not legal or regulatory advice. Sources checked on 16 October 2026. bioaccess® is not affiliated with COSMOS Scientific. Names belong to their owners and are used solely to identify them. Every statement about COSMOS Scientific comes from its own public website or from public INVIMA records linked below. Offers change, so confirm current terms with each provider.

    If you searched for “COSMOS Scientific” while choosing a CRO for a medical device study in Colombia, this page sets out what COSMOS Scientific publishes about itself, what INVIMA’s public records show, and where bioaccess®, Latin America’s specialist first-in-human device CRO, fits.

    What COSMOS Scientific says it does

    • Clinical trials for medical devices in Colombia and other Latin American countries, from first-in-human to post-market studies (cosmosscientific.com/services).
    • Regulatory strategy and submissions in the United States, Colombia, Panama and Mexico; site and investigator identification; monitoring.
    • Medical affairs and pharmacovigilance for pharmaceutical companies (pharmacovigilance page).
    • Leadership: founder and CEO Carlos A. Valverde, MD, MSc, with a Miami, Florida address (about page).

    What INVIMA records show

    • MIVI Neuroscience DAISE thrombectomy feasibility study, CRO COSMOS Scientific, approved in Acta 18 of 2021, numeral 3.1.
    • EyeFlow pilot study: COSMOS Scientific was the initial CRO. INVIMA approved the study in Acta 02 of 14 February 2024, numeral 3.5, with bioaccess® as the current CRO.

    Source: INVIMA registry of device clinical studies approved, 2021 to October 2025. Device committee minutes: INVIMA SEDMRDIV actas index.

    Colombia context every device sponsor should know

    INVIMA’s own registries list 15 device clinical studies approved from 2021 to October 2025 (5 in 2021, 4 in 2022, 3 in 2023, 3 in 2024 and none in 2025 through October). The most recent approval of a new device study in the registry is the Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13. INVIMA has not yet published any 2026 device committee minutes. Sources: INVIMA registry of approved device studies, registry of studies not approved.

    Side by side

    bioaccess® COSMOS Scientific
    Focus First-in-human and early feasibility studies for MedTech, plus biopharma and radiopharma startups Medical device trials in Latin America, plus medical affairs and pharmacovigilance
    Colombian presence Bioaccess Colombia SAS, local legal entity Bogotá headquarters per LinkedIn; Miami address on website
    INVIMA device approvals as CRO, 2021 to Oct 2025 7 of 15 (registry) DAISE (2021); initial CRO on EyeFlow

    Frequently asked questions

    What is COSMOS Scientific?

    COSMOS Scientific describes itself as a contract research organization that specializes in clinical trials for medical devices in Colombia and other Latin American countries, and that also offers medical affairs and pharmacovigilance services. Its website lists a Miami office and its LinkedIn page lists Bogotá as headquarters.

    Has COSMOS Scientific run INVIMA-approved device studies?

    Yes. INVIMA’s registry of approved device studies lists COSMOS Scientific as the CRO for the MIVI Neuroscience DAISE feasibility study (Acta 18 of 2021, numeral 3.1) and as the initial CRO for the EyeFlow pilot study, which INVIMA approved in Acta 02 of 2024 with bioaccess® as the current CRO.

    How is bioaccess® different from COSMOS Scientific?

    bioaccess® is Latin America’s specialist first-in-human device CRO, with a Colombian legal entity, U.S. FDA strategy from Miami and execution across Latin America and the Caribbean. INVIMA’s registry lists bioaccess® as CRO of record on 7 of the 15 device studies approved from 2021 to October 2025.

    Can a sponsor change CRO during an INVIMA study?

    Yes. INVIMA records CRO changes during a study. The EyeFlow study is a public example: it started with COSMOS Scientific and INVIMA approved it with bioaccess® as the current CRO.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • CogenTech and LA Research SAS in Colombia vs bioaccess®

    General information, not legal or regulatory advice. Sources checked on 16 October 2026. bioaccess® is not affiliated with CogenTech, LA Research S.A.S. or their affiliates. Names belong to their owners and are used solely to identify them. Every statement about CogenTech, LA Research S.A.S. or their affiliates comes from its own public website or from public INVIMA records linked below. Offers change, so confirm current terms with each provider.

    Many sponsors know CogenTech as a U.S. MedTech program management organization. In Colombia, its studies appear in INVIMA records under a local company, LA Research S.A.S. This page explains that link, lists what the public record shows, and compares it with bioaccess®, Latin America’s specialist first-in-human device CRO. For the general comparison, see bioaccess® vs CogenTech.

    Who CogenTech is

    CogenTech Medical & Digital Innovation describes itself as a project management organization that leads clinical trials, with a digital platform. Its LinkedIn page lists headquarters in Mahwah, New Jersey, a founding year of 2020, and a team spread across Colombia, the United States, Chile, the Dominican Republic and Spain, with about half of the staff in Colombia.

    LA Research S.A.S. in INVIMA records

    • AbSolutions Med REBUILD bioabsorbable feasibility study, Clínica Las Américas, Medellín: approved, Acta 21 of 2021, numeral 3.1.
    • SpectraWAVE OCT-NIRS first-in-human study, Angiografía de Occidente, Cali: approved, Acta 8 of 2022, numeral 3.1.
    • Imperative Care ADVANCE intracranial stent study: LA Research was the initial CRO; approved in Actas 13B and 14 of 2023.
    • AbSolutions REBUILD CTP-0002: not approved, Acta 11 of 2023, numeral 3.1.

    LA Research is also one of the most frequent filers on the INVIMA device committee agenda (amendments, safety reports and other items) from 2021 to 2025. Sources: approved-studies registry, not-approved registry, device committee actas.

    Colombia context

    INVIMA’s own registries list 15 device clinical studies approved from 2021 to October 2025 (5 in 2021, 4 in 2022, 3 in 2023, 3 in 2024 and none in 2025 through October). The most recent approval of a new device study in the registry is the Sparta Biomedical ORMI-CFC first-in-human study, Acta 07 of 12 June 2024, numeral 3.13. INVIMA has not yet published any 2026 device committee minutes. Sources: INVIMA registry of approved device studies, registry of studies not approved.

    When each fits

    If you want a PMO layer coordinating a multi-year program from first-in-human through pivotal, CogenTech presents itself as built for that. If your next milestone is a clean, FDA-bridgeable first-in-human dataset on a startup timeline, bioaccess® is built for that, with Bioaccess Colombia SAS handling INVIMA in-country.

    Frequently asked questions

    What is LA Research SAS?

    LA Research S.A.S. is the Colombian company that appears in INVIMA records as the CRO for studies associated with CogenTech. INVIMA’s registry of approved device studies lists the CRO as “COGENTECH, TECHNOLOGIES-LA” for those studies.

    Which INVIMA device studies did CogenTech / LA Research run?

    INVIMA’s registry lists LA Research / CogenTech as CRO for the AbSolutions REBUILD feasibility study (approved Acta 21 of 2021), the SpectraWAVE OCT-NIRS first-in-human study in Cali (approved Acta 8 of 2022) and, as initial CRO, the Imperative Care ADVANCE intracranial stent study (approved 2023). INVIMA did not approve a second AbSolutions protocol, CTP-0002 (Acta 11 of 2023).

    Is CogenTech a CRO or a PMO?

    CogenTech describes itself as a MedTech program management organization (PMO) that leads clinical trials, with its LearUp platform. Its LinkedIn page lists headquarters in Mahwah, New Jersey, and a team spread across Colombia, the United States, Chile, the Dominican Republic and Spain.

    How is bioaccess® different?

    bioaccess® is Latin America’s specialist first-in-human device CRO. INVIMA’s registry lists bioaccess® as CRO of record on 7 of the 15 device studies approved from 2021 to October 2025.

    Related pages

    Next step

    Comparing CROs for a Colombian study? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.

  • Salud Solutions LATAM FSP vs a First-in-Human Device CRO (bioaccess®)

    If you typed Salud Solutions into a search box, you are probably building a CRO shortlist. This article uses only what Salud Solutions publishes (salud-solutions.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Salud Solutions publishes

    Salud Solutions is a family-owned Buenos Aires boutique CRO dedicated to Latin America since 1999. It specializes in Phase IV, observational and real-world evidence studies, plus functional-service (FSP) support. It has local CRAs in Argentina, Peru and Brazil, with additional coverage in Chile, Ecuador, Colombia, Mexico, and Central America and the Caribbean, and it handles import licenses for investigational product, kits and equipment, with local representation when the sponsor has no entity in the country. It says eight of its last fourteen studies were Phase IV, focused on oncology and respiratory. We found no device page on its site.

    Salud Solutions vs bioaccess®

    Dimension Salud Solutions bioaccess®
    Core focus LATAM late-phase / real-world evidence boutique CRO and FSP First-in-human and early feasibility studies for medical devices
    Geography Local CRAs in Argentina, Peru and Brazil; coverage in Chile, Ecuador, Colombia, Mexico, Central America and the Caribbean Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial Phase IV post-authorization studies, patient registries and real-world evidence Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need a late-phase, observational or real-world study in South America, or extra monitoring capacity on a regional study, Salud Solutions is built for that.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Salud Solutions, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the Salud Solutions public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Sayani Peru CRO vs a First-in-Human Device CRO (bioaccess®)

    If you typed Sayani Latin America CRO into a search box, you are probably building a CRO shortlist. This article uses only what Sayani Latin America CRO publishes (sayanibpo.com/es/inicio) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Sayani Latin America CRO publishes

    Sayani is a small Lima-based CRO whose Spanish homepage refers to the development of medicines and medical devices. Its services are Phase II–IV operations, medical writing, pharmacovigilance and late-phase / real-world evidence.

    Sayani Latin America CRO vs bioaccess®

    Dimension Sayani Latin America CRO bioaccess®
    Core focus Peru late-phase ops, medical writing, PV First-in-human and early feasibility studies for medical devices
    Geography Lima, Peru; says it has local and regional presence in Latin America Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial Pharmacovigilance listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need Peruvian late-phase operations, pharmacovigilance or medical writing, Sayani's services match.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Sayani Latin America CRO, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the Sayani Latin America CRO public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • CIDEPRO Colombia Preclinical and Clinical CRO vs bioaccess®

    If you typed CIDEPRO into a search box, you are probably building a CRO shortlist. This article uses only what CIDEPRO publishes (cideprocolombia.org/cidepro) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What CIDEPRO publishes

    CIDEPRO is a Colombian organization offering preclinical and clinical research services to the pharmaceutical, biotechnology and medical device industries, with a tilt toward tropical and public-health product development. We found no named device study on its site.

    CIDEPRO vs bioaccess®

    Dimension CIDEPRO bioaccess®
    Core focus Colombia preclinical + clinical services First-in-human and early feasibility studies for medical devices
    Geography Medellín, Colombia Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial Regulatory consulting and product development listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need preclinical work in Colombia, or a public-health product program, CIDEPRO's mix is the right shape.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including CIDEPRO, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the CIDEPRO public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • ZEED Pharmaceutical Solutions Mexico vs a First-in-Human Device CRO (bioaccess®)

    If you typed ZEED Pharmaceutical Solutions into a search box, you are probably building a CRO shortlist. This article uses only what ZEED Pharmaceutical Solutions publishes (zeed.com.mx) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What ZEED Pharmaceutical Solutions publishes

    ZEED Pharmaceutical Solutions is a Mexico City firm that plans and follows clinical research for new pharmaceutical products and medical devices. It emphasizes NOM-012, COFEPRIS and independent monitoring, and advertises Phase I PK, bioavailability and bioequivalence studies.

    ZEED Pharmaceutical Solutions vs bioaccess®

    Dimension ZEED Pharmaceutical Solutions bioaccess®
    Core focus Mexico BE / PK and independent monitoring First-in-human and early feasibility studies for medical devices
    Geography Mexico (Mexico City) Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial Intensive pharmacovigilance (farmacovigilancia intensiva) listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If the need is independent monitoring or a bioequivalence package for COFEPRIS, ZEED fits.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including ZEED Pharmaceutical Solutions, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the ZEED Pharmaceutical Solutions public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Avant Santé Monterrey vs a First-in-Human Device CRO (bioaccess®)

    If you typed Avant Santé Research Center into a search box, you are probably building a CRO shortlist. This article uses only what Avant Santé Research Center publishes (www.avantsante.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Avant Santé Research Center publishes

    Avant Santé Research Center is based in San Pedro Garza García, Monterrey. It runs a Phase I unit for new chemical entities and BA/BE studies and promotes drug and device development on LinkedIn. Dr. Sitaramaraju Yarramraju is founder and CEO. Its device experience is less documented than its early-phase drug work.

    Avant Santé Research Center vs bioaccess®

    Dimension Avant Santé Research Center bioaccess®
    Core focus Mexico Phase I / BA-BE unit, drug-primary First-in-human and early feasibility studies for medical devices
    Geography Monterrey HQ; operations in Latin America and the USA Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial Regulatory consulting and pharmacovigilance listed Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need a Mexican Phase I or bioequivalence unit for a drug, Avant Santé is a fit.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Avant Santé Research Center, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the Avant Santé Research Center public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • EPIC Research CRO Mexico vs a First-in-Human Device CRO (bioaccess®)

    If you typed EPIC Research CRO into a search box, you are probably building a CRO shortlist. This article uses only what EPIC Research CRO publishes (epic-cro.com · epic-cro.com/who_we_are.html) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What EPIC Research CRO publishes

    EPIC Research CRO is based in Coyoacán, Mexico City. Its who-we-are page describes full-range clinical development, regulatory and post-approval services for the pharmaceutical, biotech, medical device and nutraceutical industries in Latin America. Annette G. Ortiz Austin is Director General.

    EPIC Research CRO vs bioaccess®

    Dimension EPIC Research CRO bioaccess®
    Core focus Mexico full-range CRO across product classes First-in-human and early feasibility studies for medical devices
    Geography Mexico City; Latin America Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial Post-approval services, per its who-we-are page Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need Mexican clinical development plus post-approval support under one roof, EPIC publishes that menu.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including EPIC Research CRO, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Competitor facts from the EPIC Research CRO public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.