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ISO 13485: Medical Devices
Experienced ISO 13485 Consultancy. We provide consultancy to obtain the standards as well as awareness training to ensure compliance throughout staff leaders.
ISO 13485: Medical Devices
Experienced ISO 13485 Consultancy. We provide consultancy to obtain the standards as well as awareness training to ensure compliance throughout staff leaders.
What is ISO 13485?
ISO 13485 is the medical device industry’s most widely used international standard for quality management. The standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Certifying to ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
Who is ISO 13485 for?
For organisations involved in the design, production, installation and servicing of medical devices and related services.
Benefits of ISO 13485
- Meet customer and regulatory requirements
- Increase efficiency, cut costs and monitor supply chain performance
- Outline how to review and improve processes across your organisation and products
- Expand into markets worldwide by having an audited and certified management system in place
Training
RKMS offer accredited training to support organisations in meeting ISO compliance. Our Level 3 Award in Effective Auditing and Inspection gives individuals the knowledge needed to conduct internal audits.
We deliver this course to two delegates for free as part of our ISO 13485 consultancy package, however if you wish to implement ISO 13485 internally but wish for your staff to be trained in internal auditing, take a look at our course page below.
Level 3 Award in Effective Auditing and Inspection
Give us a call to discuss your needs 0300 373 0128
Cost of ISO 13485
RKMS offers a high quality service at an affordable price. Typical costs of implementing ISO 13485 are between £3,000 and £,000 including the certification body audit fees, with the timeframe to implement roughly between 6 and 12 months. The cost of achieving ISO 13485 certification varies depending on a number of factors such as, number of staff, annual turnover, number of sites, existing documentation and complexity of audits.
If you wish to discuss your needs further and identify your options, please give us a call or request a quote below. One of our business development team members can explore your options and best advise you on which path to take.
