News

Medical engineers reviewing equipment and documentation in a clinical technology environment — compliance with EU MDR and EUDAMED requirements.

EUDAMED approaches full operational Status: New duties for EU Economic Operators

As EUDAMED nears full operational status, manufacturers, importers, authorised representatives and notified bodies must prepare for mandatory registra...

Adrianna Pyrzanowska Regulatory Affairs Associate
Scientist in protective suit performing chemical characterization tests in a medical laboratory — ISO 10993-1:2025 biological safety evaluation.

ISO 10993-1:2025 – new foundations for biological evaluation under the MDR

The 2025 revision of ISO 10993-1 introduces a more rigorous, evidence-driven system for biological evaluation, placing greater emphasis on chemical ch...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Engineer analyzing medical device user interface on multiple monitors — usability and human factors according to ANSI/AAMI HE75:2025.

Applying ANSI/AAMI HE75:2025 – Human Factors as a atrategic asset in medical device design

The revised ANSI/AAMI HE75:2025 reframes human factors and usability as central drivers of safe and effective medical device design. By structuring us...

Małgorzata Pawlikowska Head of Clinical Study Department
Regulatory specialist reviewing medical device documentation with digital data overlay — Health Canada MDL/MDEL licence and significant change requirements.

Managing medical device licence applications: new Health Canada requirements for documentation and significant changes

Health Canada has released an updated set of guidelines clarifying the requirements for Medical Device Licence (MDL) applications, expectations for te...

Emilia Geszczyńska Project Manager

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