Our services

Quality System

A tailor-made and risk-based, lean and efficient management system supports your everyday business and creates added value.

We can e.g.

  • set up a new quality system according to ISO 13485 or ISO 9001 for you and with you,
  • check and streamline your existing quality system or individual processes,
  • act as your quality representative,
  • prepare you optimally for audits or
  • train and qualify your employees in all QM matters.

Regulatory Affairs

We can optimally support you in the area of regulatory affairs, e.g. by

  • working with you to develop the right regulatory strategy based on risk,
  • taking on the role of the person responsible for regulatory compliance according to article 15, MDR, for you,
  • helping you with the classification of your products,
  • checking or accompanying your way to the CE mark of your products,
  • creating appropriate and lean technical documentation with you or
  • assisting you in selecting the Notified Body or in communicating with the authorities.

Technical Documentation

Legally compliant product files should always take the risk of the products into account, but they can be lean.

So we can e.g. for you

  • and with you define the framework which documents are required so that you know what to do,
  • and with you establish a powerfull risk management system, that shows you in detail how detailed you have to document,
  • prepare the technical documentation in full or in part,
  • check your technical documentation, correct or improve it if necessary, or
  • provide templates with which you can act yourself.

How we proceed - usually in 6 steps

1. Contacting us

You contact us e.g. by email or phone and describe your problem, your wishes or your task to us. We get a first impression and can plan the second step with you, a non-binding first meeting with you.

2. Non-binding visit

This step is usually free of charge for you. We get to know each other personally and get the most detailed overview possible of the task so that we can make you a coherent offer on this basis.

3. Offer

You will receive a meaningful offer from us, which will serve as a basis for decision-making for the next steps.

4. Kick-Off

If you give us the order on the basis of the offer, we will meet with you with the aim of getting to know you and your company, all important procedures, processes, products or/and documents as fully as possible. On this basis, we work out a detailed project plan with you.

5. Project phase

In this phase we do our work based on the project plan.

6. Project completion

Together with you, we analyze the implementation of the project. We check whether we have achieved the goals and whether we were able to meet your requirements.

What else can we do for you?

Training and Qualification

We can train and qualify your employees in all quality and regulatory affairs matters.

So we can e.g.

  • accompany the introduction of your new quality system and sensitize your employees to all quality-related issues.
  • train your medical device advisors in legal principles based on the MDR / IVDR and the German MPDG.
  • Familiarize your employees with the requirements of ISO 13485, the MDR or the IVDR.
  • train new employees in the areas of QM or RA for you.

Micro-Consulting

Do you have specific questions? Please do not hesitate to contact us. We help you to master even small challenges.