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
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.
Common Criteria for Information Technology Security Evaluation
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
Clinical evaluation of eyeglasses
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.
Clinical Evaluation for Medical Devices in China
The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.