Quality Management

Quality Management

Audit Management

Internal audits, mock inspection,
and unannounced audits

There is no reason for sleepless nights and anxiety when it comes to an impending audit: Our goal is to alleviate your fear of audits and prepare you and your employees in the best possible way.

Audit Management

Internal audits, mock inspection,
and unannounced audits

There is no reason for sleepless nights and anxiety when it comes to an impending audit : Our goal is to alleviate your fear of audits and prepare you and your employees in the best possible way.

Table of contents: Audit Management

Challenges in Audit Management -
you know the drill

The next audit of your Notified Body is pending yet you have not yet performed all required internal audits?

You are planning an important supplier audit to qualify a distributor, but you do not have the time to do it?

Your market surveillance authority has indicated its intention to carry out an inspection and you are concerned about a close examination of the requirements from national laws and regulations?

Or the FDA has scheduled an inspection. You are uncertain about the procedure and how to prepare yourself properly?

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60
 

Qtec as your partner

Whether you are looking for a tough audit or simply want to prepare your audit team, we can offer support in form of professional execution of

  • internal audits (also unannounced),
  • mock inspections,
  • supplier audits and
  • other inspections
    • of your QMS or
    • Technical Documentation.

Our former auditors from Notified Bodies or experienced lead auditors adapt the audit to your needs and audit criteria, for example in the areas of

  • EN ISO 13485
  • 21 CFR 820
  • MDSAP
  • MDR (EU) 2017/745 & IVDR (EU) 2017/746
  • GLP, GCP, China GMP ...

and offer a valuable head start for the upcoming audits or inspections of Notified Bodies or authorities.

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