CRO organization for the MedTech industry

Pure Clinical is a flexible Contract Research Organization (CRO) and consultancy combining expertise in clinical research, MDR/IVDR compliance, and certification to help manufacturers bring their medical devices safely and efficiently to the European market. As a Research & Development Centre, we go beyond execution - developing forward-looking solutions that anticipate regulatory changes and accelerate innovation across the MedTech sector, from concept to clinical validation and certification.

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Why is it worth it?

303+ satisfied
clients

512+ completed
projects

148+ completed
clinical trials

74+ cooperating
clinical sites

230+ successfully
completed certifications

37+ regions our clients
come from

End-to-end R&D support for MedTech innovation

We guide manufacturers and distributors of medical devices and IVDs through every stage — from idea and research to regulatory compliance, certification, and market introduction. Our R&D status translates into tangible value for your business.

Enhanced credibility and
investment readiness

EU and national funding up to 80%

Faster product development
and market launch

Up to 40% tax benefit
for R&D activities

Process

The certification process for a medical device is dynamic and requires close collaboration between the manufacturer, notified bodies, and regulatory authorities. It is a key element in ensuring that medical devices meet the highest standards of quality and safety.

Regulatory
strategy

Business
 support

Risk  management

Pre-clinical evidence

Clinical trials

QMS implementation

Technical Documentation

Certification & Regulatory appovals

Post-Market Surveillance

Case studies

+120

Developed case studies

Clinical performance study of SARS-CoV-2 & influenza A/B antigen test

This study evaluated the clinical performance of the SARS-CoV-2 & Influenza A/B Antigen Test under conditions of use of the device by a non-professional user. The study focused on the sensitivity and specificity of the test and the usability of…

Clinical Evaluation of Class III Vascular Implants – Transition from MDD to MDR

The authority responsible for regulating medical devices in the United Kingdom is the MHRA. If the manufacturer is based outside the UK, they must appoint a UK Responsible Person (UKRP).

Efficacy and safety evaluation in clinical trial of dermal filler

This study assesses the efficacy and safety of the dermal filler for treating medium facial lines, including nasolabial folds and marionette lines, over a 24-month follow-up period. It aims to generate comprehensive clinical data through post-market clinical follow-up (PMCF).

Usability Study of an Inhaler

The purpose of the usability study was to evaluate whether the interface of a newly developed inhaler allows for safe and effective use by diverse patient populations. The study involved 30 participants and included comprehensive planning, testing in simulated environments,…

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This is what clients say about us

Pure Clinical always delivers the highest quality of service. Read a few of the latest testimonials from our clients who appreciated our expertise, commitment, and comprehensive support throughout their projects.

Professional expertise and problem-solving mindset

The Pure Clinical team members have expert knowledge and competencies, as well as they exhibit openness and readiness towards solving problems or any doubts. I therefore strongly recommend Pure Clinical as a potential business partner and their services in these areas: designing, managing and monitoring the clinical investigation.

SD Biosensor Ltd.

Insights from the industry

Pure Clinical and MDR Regulator join forces under one brand

Autumn is a time of major change for us. After weeks — and indeed months — of preparation, Pure Clinical and MDR Regulator have officially merged and...

Katarzyna Wesołowska Board Member

ISO 13485:2016 reconfirmed – regulatory and quality system stability secured until 2030

During the recent ISO/TC 210 Working Group 1 meeting held in Arlington, Virginia, it was officially confirmed that ISO 13485:2016 remains valid and un...

Katarzyna Wesołowska Board Member

FDA launches real-time reporting of adverse event data

What this means for stakeholders Patients: immediate visibility of new adverse events linked to marketed products. Healthcare professionals: timely si...

Adrianna Pyrzanowska Regulatory Affairs Associate

ISO 14155:2020 – Upcoming Revisions to the GCP Standard for Clinical Investigations of Medical Devices

The International Organization for Standardization (ISO) is finalizing updates to ISO 14155:2020 to align Good Clinical Practice (GCP) with the realit...

Małgorzata Pawlikowska Head of Clinical Study Department

FDA – Draft Guidance on Comparative Efficacy Studies in Biosimilar Evaluation

The U.S. Food and Drug Administration (FDA) has proposed a major revision to its biosimilar guidance, outlining when comparative efficacy studies (CES...

Adrianna Pyrzanowska Regulatory Affairs Associate

MHRA – Updated Guidance on Clinical Investigations of Medical Devices in the United Kingdom

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released an updated Guidance for Manufacturers on Clinical Investigations of Med...

Agnieszka Czapko Head of Regulatory and Start-up Department

Pure Clinical at the We! Are Clinical Research Conference

Three days filled with inspiration, knowledge, and discussions with people deeply involved in the world of clinical research. Izabela Chodara, Direct...

Izabela Chodara Director of Strategy and Operations

Close-up of scientists in lab coats writing notes on paper in a research laboratory.

Updated MHRA requirements for clinical investigations of medical devices

In September 2025, the MHRA published harmonised guidance and validation checklists for sponsors and investigators planning clinical investigations in...

Małgorzata Pawlikowska Head of Clinical Study Department

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