Instituto Pedro Nunes (IPN)

IPN supports medical device manufacturers in implementing Quality Management Systems according to ISO 13485, aligned with Article 10 of the MDR, preparing organizations for certification audits.

Supports manufacturers, distributors and importers of medical devices in the CE marking process, in accordance with Article 20 of Regulation (EU) 2017/745 (MDR), including the implementation and review of the Quality Management System according to ISO 13485, the preparation or updating of Technical Documentation (Annexes II and III), the clinical and biological risk assessment, the UDI/EUDAMED registration, the submission to Notified Bodies and, where applicable, support in identifying an authorized representative.

The auditors from IPN's regulatory support unit conduct remote and fully independent audits of quality systems, both for companies with ISO 13485 certification already implemented and for companies that wish to prepare for their first ISO 13485 certification audit.

Preparation of the biological assessment report in accordance with ISO 10993. Biological assessment is an essential process in the development of medical devices, designed to evaluate their safety and biocompatibility in interaction with biological systems, ensuring that the materials used do not cause adverse biological responses, in accordance with ISO 10993, through the preparation of a Biological Assessment Plan (BEP) and a Biological Assessment Report (BER) that demonstrate the safety and regulatory compliance of the device.

Preparation and review of the Post-Marketing Surveillance Plan (PMS), as well as the preparation of PMSR or PSUR reports, ensuring continuous monitoring of the safety, quality and performance of medical devices throughout their entire life cycle, in accordance with regulatory requirements.

The RDM and RDIV establish, in article 10, paragraph 9 and article 10, paragraph 8 respectively, the requirements for the manufacturer's QMS (according to ISO 13485 and/or ISO 9001). Although not explicitly stated, ISO 13485 is the most suitable quality management system standard for medical device companies. To effectively implement ISO 13485, manufacturers (and other economic operators) need to use documentation to control their internal processes. IPN's regulatory support unit helps manufacturers identify/create the necessary processes and develop/update the associated documentation to demonstrate compliance with the standard. The documentation is not restrictive and is tailored to each organization. Thus, to meet the requirements and also the specific needs of operators, our consultants work closely with representatives from each section or department. After developing an implementation plan, our team helps manufacturers build their system with the necessary quality manual and documented procedures and records, in order to prepare them for a certification audit.