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Conformity Assessment Procedure
Handling processes can be speeded up.
A first step is our following sequence plan in accordance with the AIMD, MDD, IVDD directives for medical devices.
1. Establishing contact
First, we present ourselves and services and learn about your company and your products. We then discuss and determine further procedures together as early as in the product development phase. It allows better coordination of time schedule for your product launching.
2. Quotation
We will then prepare a quotation for you covering the services you request to achieve CE marking This includes QM audit, product testing, examination of the technical documentation, etc.
3. Order
After receipt of the order, we will discuss any open questions and coordinate the project handling together with you.
4. Technical documentation
Prior to the audit, selected documents out of the technical documentation will be checked for plausibility and for conformity with directive requirements.
5. For all AIMD, MDD Class III and IVDD List A products
Examination of the design documentation or EC type-examination. You submit documentation for the product design and we will check its completeness and plausibility. Aftet testing your product and the associated documentation, we will issue a report on the test results. If the assessment is positive, you will receive the following certificates:
MDD: Annex II.4 or Annex III
AIMD: Annex 2.4
IVDD: Annex II.4 List A or Annex V
6. Voluntary pre-audit
Based on the scope of the pre-audit on your request, you will receive an audit report in which potential improvements will be pointed out.
7. Review of the QM documentation
The QM documents, such as the Quality Manual as well as relevant procedures, will be assessed by us prior to the audit, and you will receive a report on our findings.
8. Certification audit
Prior to the audit, you will receive an agreed audit plan. During the audit, the operations in your company and the implementation and effectiveness with its applicable directive and standards will be examined. In the process, we will particularly assess the conformity of the products with the essential requirements. The team of auditors always includes at least one expert on your product range. All relevant production sites are included in the scope of the audit. You will receive a detailed report on the performed audit that also includes advice for improvement.
9. Certificate/approval
If the audit result is positive, you will receive an approval for the selected conformity assessment procedure. Afterwards, we will carry out surveillance audits every twelve months and a recertification audit after five years.
10. Declaration of Conformity
You are now permitted to issue the declaration of conformity for your medical devices with the CE Marking including the identification number of the "Notified Body" for the European market.