Quality Planning for Medical Devices

01 | 01 | 09

Both the EN ISO 13485 standard, the FDA Quality System Regulation and the Medical Device Directive include requirements for quality management system planning.

The course is designed to give delegates an understanding of the requirements for establishing a quality plan which defines the quality practices, resources and activities relevant to devices that are designed and manufactured.

Om kurset


The objective of the course is to give the delegates an understanding of both the EU and the US quality planning requirements. Furthermore, the delegates will get an understanding of how to establish a company quality plan covering all aspects of the product realization process together with all the elements forming such a plan.

  • Requirements of the EU and the US regulatory system regarding quality planning
  • Quality Planning versus Standard Operating procedures (SOP)
  • The elements and the format of a quality plan will be covered including methods to maintain it over the product realization life-cycle
  • The different sections of the company quality plan will be covered such as development life-cycle plan, product verification plan, product validation plan (including planning for obtaining clinical data) and Risk Management Planning.
  • The course will follow the recommendation as defined in the standard ISO 10 005, Quality Management Systems – Guidelines for quality plans

The course is particularly suitable for those who:

  • are or will be involved at some level in the implementation of compliance to FDA/EU Regulations and/or
  • have some experience of maintaining quality management systems, developing procedures and plans.
Udbytte After the course you will be familiar with requirements for establishing a company quality plan.
Poul Schmidt-Andersen,  B.Sc.E.E., B.Comm., Copenhagen Medical Devices Consulting ApS.
Pris kr. 4000,- ekskl. moms
The price is excluding VAT. The course fee includes lunch and refreshments as well as course material.

Please read more here for information about registration and cancellation.
DS Certificering A/S
Kollegievej 6
2920 Charlottenlund

Registration and coffee at 08:45-09:00

Tidspunkt Den 1. januar 2009, kl. 09:00-16:30

DNV GL Business Assurance Denmark A/S
Tlf.: +45 39 45 48 00
E-mail: dnvbadk@dnvgl.com
CVR: 32934382