Ministerial Decision 4822/2025 (Medical Devices)

Yes. ISO 13485 is the ideal quality-system basis on which compliance with the national requirements is built.

Mainly those distributing, storing or supplying medical devices. We check the scope for your case.

Typically 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.