Medical  Device  &  QA  Consultancy

CONFORMANCE ROUTE CHOICES

Any Medical Device falling into Class IM, Class IS, IIa, IIb or III of the Medical Device Directive (93/42/EEC), must encompass the following 2 basic elements, as part of a Compliance Strategy;

- A Technical File - covering all Safety and Performance issues, and

- Either basic GMP or a Formal Quality System (eg: ISO 13485:2003 or ISO 9001:2000 or both) depending on your company's business objectives.

NB: Class I products (non-measuring and not supplied sterile) do not need a formal or full quality system. Basic GMP is sufficient, with documented procedures covering the following areas;

- Goods receiving inspection and acceptance.

- Final inspection and acceptance.

- complaint handling

- non-conforming product control

- record keeping

- incident / vigilance reporting

- post market feedback

- advisory notice issue and product recall

Class I devices (non-sterile & non-measuring function)

  Annex VII - (Internal Control of Production+ 93/42/EEC) CLICK HERE for information on a "Distance Self Certification" Strategy for Class I Devices, at a minimum cost.

    (which includes a Technical File in accordance with Annex VII)

    Self Certification ie: No Notified Body audit necessary.

Class IIb and Class III devices

  Annex II - (ISO 9001:2000 /   ISO 13485:2003 + 93/42/EEC)

    (which includes a Technical File for class IIb OR a Design Dossier for Class III)

   Notified Body audit of all the above is mandatory.

Class IIa devices

  Annex VI + Annex VII (ISO 9001:2000 or ISO 13485:2003 + 93/42/EEC).

(which includes a Technical File in accordance with Annex VII)

Notified Body audit of all the above is mandatory.

Type Test Routes

The following Type Test routes are also available

    Annex IV + Annex VII for Class IIa Devices

    Annex III + Annex IV OR Annex V OR Annex VI for Class IIb Devices

    Annex III + Annex IV OR Annex V for Class III Devices

Class IIa devices

  Annex V + Annex VII - (ISO 9001:2000 + 93/42/EEC) .or ISO 13485:2003

    (which includes a Technical File in accordance with Annex VII)

    Notified Body audit of all the above is mandatory.

Medical Device & QA Consultancy offers the following related Services;

 à Implementation of any of the above Strategies, at any level from MINIMAL/STRATEGIC involvement to FULL involvement.

DOCUMENTATION REVIEWS

With Certificate of Conformance provided after successful review

   Class I Technical File - Self Certification (no Notified Body)

   Risk Management documentation review

  Design Dossier