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Conformity Assessment Procedure
Handling processes can be speeded up. A first step is our following sequence plan (for medical devices in accordance with the AIMD, MDD, IVDD directives):
1. Establishing contact
First, we present ourselves and our range of services and get to know you, your company and your products. We then determine further procedures together. Early establishing of communication, e.g. as early as in the product development phase, allows for better coordination of the time schedule for the market launch of your product.
2. Quotation
We will then prepare a quotation for you covering the services you request on the way to acquiring CE marking (QM audit according to EN ISO 13485 and EN ISO 9001, 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 the requirements of the directive.
5. For all AIMD, MDD Class III and IVDD List A products
Examination of the design dossier or EC type-examination. You submit to us the documentation on the product design (design dossier), and we will check it for completeness and plausibility. Or we test your product and the associated documentation. We will then issue a report on the test results. If the assessment is positive, you will receive the following certificates:
6. Voluntary pre audit
We will base the scope of the pre audit on your wishes. You will receive an audit report in which potential for 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 audit plan agreed on with you. During the audit, the operations in your company will be examined and thus the implementation and effectiveness of the requirements of the applicable directive and the relevant standards. 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 includes also advice for improvement.
9. Certificate/approval
If the audit result is positive, you will receive an approval for the selected conformity assessment procedure.
In addition, certificates according to QM standards EN ISO 3485 and where required EN ISO 9001 are issued. 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, to provide them with the CE marking including the identification number of the "Notified Body" and to place them on the European market.
Contact us - we are looking forward to hearing from you!