Quality management that works.

ISO 9001 is a general quality standard for all industries, while ISO 13485 was specifically developed for the medical device industry and addresses the Regulatory Requirements of the MDR or IVDR as well as other international laws and regulations. For Medical Device manufacturers, ISO 13485 is the definitive standard – it cannot be replaced by ISO 9001, although both standards can be applied in parallel.

This depends on the baseline status. A complete re-build typically takes several months – from process analysis through documentation to the first Internal Audit. If structures already exist, it often goes significantly faster. We analyze your current situation and develop a realistic roadmap – without unnecessary additional effort.

For those who want to get started faster: our ready-made QM System is immediately implementable and skips the entire development process.
→ QM System with Update Service

At least once a year, all relevant processes and areas must be reviewed through Internal Audits. The exact frequency depends on company size, complexity, and risk profile. Internal Audits are also a prerequisite for the external certification audit – and a central element of an effective Quality Management System.

Notified Bodies or Competent Authorities conduct a detailed assessment of the Technical Documentation. They specifically review whether the documentation is complete, consistent, and traceably structured and whether all Regulatory Requirements of the MDR or IVDR, as well as normative requirements, are met. All preclinical and clinical safety and performance evidence is examined – including risk management evidence, usability, Biological Evaluation, sterilization, Clinical Evidence, etc., and verifying whether all General Safety and Performance Requirements of Annex I of MDR or IVDR have been assessed and fulfilled.

That depends very much on the initial situation. Here at regular services, we know which aspects are critical during an audit, so an initial review is very quick and takes just a few hours.
Based on this review, we can make a realistic estimate of the time required – ranging from a few days to several weeks.


If further testing is required, the time needed will also depend on the capacity of the testing laboratories. In such cases, the process may take several months.

Notified Bodies review whether the Quality Management System is fully documented, effectively implemented, and continuously improved. The focus is on processes, responsibilities, risk management, the CAPA system, and the link to Technical Documentation. We prepare you systematically for these audits – so you can respond confidently.

CAPA stands for Corrective and Preventive Action. An effective CAPA system is one of the central requirements of ISO 13485 and is regularly reviewed in audits. CAPA applies whenever nonconformities, complaints, or audit findings occur and root causes must be systematically analyzed and permanently resolved. We support you in establishing CAPA processes that actually work – not just documented ones.

Not necessarily. Depending on role, Product Class, and market strategy, a Quality Management System according to ISO 13485 can also be meaningful without formal certification – for example, for process optimization, faster time-to-market, or as preparation for later certification. For manufacturers who want to place products on the EU market, certification is generally helpful but not strictly required. We will work with you to determine which requirements apply to your specific situation.