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.
Challenges in Audit Management -
you know the drill
The next audit of your Notified Body is pending however 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?
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
- Technical Documentation
- or Audit Trainings.
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.
News
20 years of medical technology approval
We are celebrating our anniversary. We have been a partner to the healthcare industry for 20 years and support companies with the approval of medical products
Regulatory Affairs Update 25/23
Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
Regulatory Affairs Update 15/23
Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
Post-Market Surveillance in China
In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
