You want to change to a different certifier and/or the notified body, but how? Our step-by-step approach can help you.

Uncover unknown treasures in your company by changing your certifier and/or your Notified Body
There are a multitude of reasons which motivate certified manufacturers of medical devices to change their certification body and/or their Notified Body. For example, the services offered do not cover all your market requirements or the execution quality of the service provided does not meet your high expectations or existing potentials resulting from the certification of your management system and serving as a continuous business development and growth driver are not exploited.

Raise these treasures together with DQS-Medizinprodukte GmbH
With us, you have an internationally recognized partner with extensive medical device expertise at your disposal, who also offers a wide range of services related to the auditing of management systems and product approval via the extensive global DQS network. A comprehensive range of training courses and seminars is also available. With the DQS-MED certification symbol you have the opportunity to promote your certification and to position yourself positively in the market.

How do you initiate this process?
Basically, there is always the possibility for DQS Medizinprodukte GmbH to issue its own certificates based on existing certifications of other accredited certification and/or notified bodies. In the eight phases described in more detail below, the minimum requirements to be observed in this regard are explained in more detail. With our phase model we would like to guarantee an uncomplicated and smooth takeover and avoid a time without certificates for you.

The DQS MED step-by-step approach to a smooth transfer

1. Contact
- We inform you about all necessary steps for the transfer of your certificates
- You will receive information about the documents and evidence to be submitted to ensure a smooth transfer
- If required, we can also discuss the general conditions with you in a personal meeting

2. Submission of documents
- Copies of your certificates
- Reports on the last certification cycle
- If applicable, deviation reports, incident reports, recalls
- Your basic data (MA, locations, products, etc.)

3. Evaluation of the documents and preparation of an individual offer
- On the basis of the evidence submitted by you, you will receive an offer showing the scope and costs of the transfer
- If the offer is accepted, we will initiate the next phase
- Our contract for the change of the Notified Body, is a mandatory part of the new business relationship for directive assessments (93/42/EEC)

4. Order confirmation
- You will receive an order confirmation from us, in which the auditor designated for you is named

5. On-site assessment by our auditor
- Our auditor will coordinate the audit planning with you and carry out the audit on your premises
- The audit can also be carried out separately from the regular audit dates.

6. Review of audit results
- DQS Medizinprodukte GmbH reviews the audit evidence submitted by the auditor and decides on the issuance of the certificate.

7. Issuance of the DQS-MED certificate
- In case of a change of the certification or notified body in the course of a repeat audit, you will receive a certificate with a new term. In the case of surveillance or "interim" audits, we will issue you a certificate with the remaining term of your old certificate.

8. Regular surveillance
- The auditing of your management system or the approved products will take place at least once a year in the known cycles (three or five years).

Do not hesitate to involve us in your decision. Let us lift your treasures together.

Michael Bothe

Michael Bothe heads the certification decision board for Active Medical Devices and is also a lead auditor. He is also involved in standardization at the German Institute for Standardization (DIN) and the German Commission for Electrotechnical, Electronic & Information Technologies (DKE) and coordinates continuing education activities for customers. His interests include integrated audits as well as process optimization of conformity assessment procedures.


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