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
In Vitro Diagnostics manufactured and used within EU Health Institutions – In-House Devices (IH-IVD)
In-house IVD: in-house laboratory tests for safe and reliable diagnostics. Find out more about requirements and regulatory specifications!
In vitro diagnostics – the importance of in vitro diagnostics for patient management and the health of society
In vitro diagnostics (IVDs) enable early disease detection & precision treatment. Learn how PCR, AI & lab tests improve healthcare & patient outcomes!Scientific Advice from the Medical Device Expert Panels on SARS-CoV-2-IVDs
The Medical Device Coordination Group (MDCG) requested scientific advice from the European Medicines Agency (EMA) to re-evaluate the classification of SARS-CoV-2 in the context of in vitro diagnostic medical devices (IVDs).Opportunity and challenge: Regulatory requirements for AI-based medical devices
AI has the potential to revolutionize healthcare and improve the lives of millions of people - but only if it is used safely and reliably.