– Your partner in Quality Assurance & Regulatory Affairs for Medical Devices
Symbioteq is a consultancy company, working with quality assurance (QA) and regulatory affairs (RA) for medical devices (general medical devices as well as in vitro diagnostic and active implantable medical devices).
Our core value is patient safety, as well as protecting our clients’ and colleagues’ safety and security. Symbioteq was established in 1994, just as the medical device regulations were taking shape in Europe, and has since then kept working with QA and RA for medical devices.
Our vision is not only to help our clients satisfy regulatory requirements, but with the objective of helping them develop and maintain quality management systems and product documentation adapted to their operations. Thanks to our wide experience and in-depth knowledge in the different areas related to QA and RA for medical devices, we can guide our clients to a fast and cost-efficient market entry.
Our services cover the entire product life-cycle – from concept creation of new products to post-production activities. Our consultants are also experienced course instructors and we can more or less also tailor make any education according to our customers’ needs within the medical device field.
Examples of Consultancy services that Symbioteq provides:
• Regulatory strategy, including Product Classification
• Strategy for coming EU Regulatory Requirements
• Development of management systems (ISO 13485,
• QSR, ISO 9001 etc.) including GAP-analysis of new ISO 13485:2016
• Internal audits
• Technical file
• Product Registration USA, Canada, Australia, Asia, Middle East etc.
• Biological Evaluation according to ISO 10993
• Risk Management according to ISO 14971
• Development of or guidance in Usability engineering process (ISO 62366)
• Standard guidance, such as gap analysis and interpretation (IEC 60601-series, IEC 61010-series etc.)
• Project management with focus on QA/RA
• Act as QA / RA manager
• Regulatory due diligence
• Etc etc
For further information regarding Symbioteq, see www.symbioteq.com