Medical Devices
Medical device manufacturers under EN ISO 13485 — from class I product development to class IIb serial production.
What makes this industry distinctive
EN ISO 13485 is the foundation — real audit rigour comes from the interplay with MDR (or IVDR), technical documentation and post-market surveillance. We work with manufacturers producing class I to IIb, and with suppliers feeding into the supply chains of regulated manufacturers.
Situations clients come to us with
Initial certification to EN ISO 13485
You are developing a medical device and have to build the QMS before the Notified Body arrives.
MDR transition not yet complete
Technical documentation is lagging; PMS and PMCF are not yet systematically implemented.
Software as a Medical Device (SaMD)
IEC 62304 requirements hit your development process — and that process is more agile than formalised today.
Supplier audits by manufacturers
You are a supplier to a manufacturer and have to pass an audit to EN ISO 13485 requirements.
Which standards matter in this industry
EN ISO 13485
QM standard for manufacturers and suppliers of medical devices.
MDR (EU 2017/745)
EU regulation on medical devices — integration with ISO 13485.
IEC 62304
Software lifecycle for medical software.
ISO 14971
Risk management for medical devices.
EN ISO 13485 + class IIa technical documentation
Start-up, 12 employees, developing a class IIa diagnostic product. Starting point: product close to development readiness, QMS rudimentary. Approach: build EN ISO 13485-compliant QMS, structure technical documentation, risk management to ISO 14971, preparation of the Notified Body audit. Result: ISO 13485 certification after 8 months; technical documentation subsequently filed and released.
Anonymised example, representative of our work in this industry.
View more case studies →Where do you stand today?
In a 30-minute initial consultation we clarify industry, standard and starting point.