Finaler Blog

Leitfaden Prozessvalidierung - Ruhige Fahrt statt stürmischer See

leon.weissenhorn@metecon.de (Leon Weißenhorn) — Fri, 05 Jun 2026 08:53:58 GMT

Ready for another journey into the world of process validation? In Part 1 of our Guide to Process Validation, we discussed the requirements of Annex I (General Safety and Performance Requirements (GSPR)) of Medical Device Regulation (EU) 2017/745 (MDR) and of ISO 13485:2016 for validation in production. We explored alternatives to validation and explained the ideal decision-making process. In this second part, we will apply the concepts introduced using an examplary process and provide detailed guidance on how to implement validation in practice.

Metecon x Flinn: Partnership for AI-powered regulatory processes

alexander.fink@metecon.de (Alexander Fink) — Wed, 03 Jun 2026 10:51:27 GMT

Searching country-specific safety databases, ongoing literature reviews, and audit-ready reports under the MDR and IVDR: What PMS requires today is still done manually in many companies. This ties up resources that are urgently needed elsewhere. Automation is the obvious solution, but success depends not only on choosing the right tool, but also on whether it is implemented in a regulatory-compliant manner. The partnership between Metecon and Flinn shows how the two go hand in hand.

Metecon x CertHub: Partnership for controllable and transparent regulatory processes

alexander.fink@metecon.de (Alexander Fink) — Tue, 12 May 2026 06:30:00 GMT

Regulatory requirements are becoming more complex, while expectations for transparency, traceability, and speed are rising. Certificates, approvals, product data, and global regulatory processes must be consistent and manageable at all times. In many companies, however, this information is still managed in a fragmented manner – with corresponding risks to efficiency and compliance. The partnership between Metecon and CertHub demonstrates how these challenges can be addressed within an integrated system.

EN ISO 13485: Certification Requirements and Strategic Relevance | Metecon

sandra.reuter@metecon.de (Dr. Sandra Reuter) — Mon, 04 May 2026 06:45:00 GMT

EN ISO 13485: Dr. Kirsten Theiling, QMB at Metecon, explains when certification is required and why manufacturers, suppliers, and service providers benefit from certification.

Who needs a QMS under MDR/IVDR? Roles, responsibilities, and EU certificates explained

kirsten.theiling@metecon.de (Dr. Kirsten Theiling) — Mon, 23 Mar 2026 07:45:00 GMT

Who needs a QMS under MDR/IVDR? This guide by Dr. Kirsten Theiling, QMB at Metecon, clearly outlines roles, obligations, and EU certifications for manufacturers, distributors, and service providers.

Metecon x meddevo – Partnership for Digital Technical Documentation

alexander.fink@metecon.de (Alexander Fink) — Tue, 03 Feb 2026 23:00:00 GMT

The requirements for technical documentation and regulatory affairs are constantly increasing; digital solutions are indispensable. Metecon and meddevo have enjoyed a close, trusting working relationship for many years. Now we are making this long-standing partnership visible: Together, we support manufacturers in making their technical documentation efficient, compliant, and future-proof.

Metecon X MedBoard - Partnership for Digital Regulatory Intelligence

alexander.fink@metecon.de (Alexander Fink) — Tue, 18 Nov 2025 23:00:00 GMT

Regulatory requirements continue to grow in complexity, and digital processes have become essential. For many years, Metecon and MedBoard have worked closely and with deep mutual trust – a naturally evolved partnership that now helps manufacturers navigate digital Regulatory Affairs with clarity and confidence.