Quality & compliance for medical devices.
ISO 13485:2016 sets the quality requirements for manufacturers and suppliers of medical devices, a basis for CE marking (MDR).
Manufacturers, distributors and suppliers of medical devices.
Practically yes. Although not strictly mandatory, ISO 13485 is the de facto way of demonstrating a compliant quality system for the MDR Regulation.
Yes. It shares common roots but adds strict requirements for traceability, risk management and regulatory compliance specific to medical devices.
Yes. It covers the whole chain — design, manufacture, storage, distribution and support of medical devices.
When your business is already ready, we can schedule the audit and certificate issuance in under 3 weeks. Typically, though, it takes 2–4 months, depending on your size, complexity and maturity. We give you a clear timeline from the start.
The cost depends on the size of your business and the scope of the project. The initial assessment is free and you receive a transparent quote with no hidden charges. The consultant fee and the certification body fee are clearly separated.
The certificate is valid for 3 years, with annual surveillance audits by the body. We support you throughout so you maintain compliance with no stress.
No — we are independent consultants. We prepare you impartially and stand by you at the audit by any accredited body of your choice.
Absolutely. We tailor the system to be practical and lightweight, with no unnecessary bureaucracy — it works equally well for small and large companies.
Yes. The cost of ISO certification is an eligible expense in many ΕΣΠΑ programmes for SMEs, so a significant part can be covered by a grant. We inform you of active programmes and the funding rate.
Book a free initial assessment. We will analyse your needs and recommend the optimal standard and timeline.