Quality Management
Further Quality Management Systems
GLP, GCP, and GMP
You should be familiar with these QM Systems if you carry out tests, studies, clinical investigations or, verification tests in your own company.
Frequently asked questions when conducting tests and studies
Have you asked yourself some of these questions?
- Is my testing division a laboratory and, does it have to comply with ISO 17025?
- To what extent does my testing department, which performs verification testing, need to be independent of the rest of the company?
- How do I integrate the requirements for laboratories into my existing QM System?
- Do I have to meet specific requirements to conduct clinical studies?
- What do I have to consider when conducting clinical studies?
- Are the requirements for laboratories the same in all European countries? What does the FDA require?
These are just some of the questions you might be asking yourself - or have probably already asked yourself - when it comes to QM requirements for your laboratory for clinical studies.
GLP, GCP and, GMP - These are the differences
The common QM Systems have many overlapping areas, such as document control or management responsibility. Systems such as GLP, GCP, and GMP additionally include the specifics of the respective location and the activities carried out there:
GLP - Good Laboratory Practice are requirements to the QM System for laboratories, which perform non-clinical safety inspections
GCP - Good Clinical Practice are QM requirements for laboratories conducting clinical studies.
GMP - Good Manufacturing Practice, are requirements for a QM System in production
qtec as your partner
Our qtec experts :
- Are ready to check which country-specific requirements apply to you.
- Are eager to implement or improve your QM system in the necessary specialist areas.
- Are happy to ensure compliance in all departments and reliable results from your tests and studies.
News
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.
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.