ISO 13485 CONSULTING: SUCCESSFULLY MASTERING THE PATH TO CERTIFICATION
ISO 13485 is the internationally recognised standard for quality management systems in the medical device industry. Certification to this standard ensures that a company fulfils the requirements for the quality and safety of medical devices. For medical technology companies, certification to ISO 13485 is often an important competitive advantage.
What is ISO 13485?
ISO 13485 is based on ISO 9001, the international standard for quality management systems. However, it contains additional requirements that are specifically tailored to the medical device industry. The standard specifies requirements for the following areas:
- Management responsibility
- Quality management system
- Resource management
- Product realisation
- Measurement, analysis and improvement
WHY IS ISO 13485 IMPORTANT?
ISO 13485 offers medical technology companies numerous advantages:
- Improving the quality and safety of medical devices
- Increasing customer satisfaction
- Increasing competitiveness
- Facilitation of market access
- Reduction of liability risks
HOW CAN ISO 13485 CONSULTING HELP?
Implementing an ISO 13485-compliant QM system can be a challenge for companies. ISO 13485 consulting can help companies overcome the following challenges:
- Understanding the requirements of the standard
- Developing and implementing a QM system
- Preparing for the certification audit
WHAT SERVICES DOES AN ISO 13485 CONSULTANT OFFER?
ISO 13485 consultants offer a wide range of services, including
- Gap analysis
- training courses
- Development of QM documents
- Internal audits
- Coaching
ISO 13485 consulting can help medical technology companies realise the benefits of certification to this standard. Expert advice can help companies understand the requirements of the standard, implement a QM system and prepare for the certification audit.
PeRoBa Quality Management from Munich - Customised quality management and ISO 13485 consulting
Consultancy, implementation, audits and QM tools from a single source
PeRoBa GmbH Munich is a service provider with many years of experience in quality management, especially in the automotive
pharmaceutical and mechanical
engineering sectors. We help with all
important standards (ISO 9001, ISO 13485, ISO 45001,...) on the way to
certification or re-certification. We also work closely with universities and research institutes. Managing Director Dr Scherb
teaches as a lecturer, for example, at the Hamburger Fern-Hochschule, the FOM in Munich and is also a speaker at the
TÜV-Süd Akademie, the Bildungswerk der Bayerischen Wirtschaft and many other institutions.
We look forward to hearing from you. The best way to reach us is by phone at the number
+49 8106 / 230 89 92
(more
contact options)
Quality management ISO 9001, VDA 6.3 and IATF 16949 - www.peroba.org