You are involved in the sector of medical devices: ISO 13485 certification under accreditation proves that you provide a high quality service, in compliance with regulations and the requirements of your customers and business associates.
ISO 13485 certification helps you to ensure your customers that you comply with regulations, that their requirements are taken into account, and that your activity and the associated risks are under control.
You display an image of competence and professionalism through the implementation of a demanding and recognised standard.
Quality Manager - MSM Medimpex
“Having the official certificate gives us a competitive edge in the market, because it is recognized proof of the quality of our production.”
The term "medical device" refers to thousands of different products, ranging from the simplest (e.g. toothbrush) to the most complex (e.g. connected prosthesis). The regulatory framework for the sector is becoming stricter; with the arrival of European Union Regulations 2017/745 and 2017/746, manufacturers must demonstrate risk management throughout the life cycle of the medical device. To do this, manufacturers and all other stakeholders in the medical device industry can rely on ISO 13485.
The ISO 13485 standard is a voluntary certification standard for the quality approach developed for the medical devices industry. Its full title "Medical devices - Quality management systems - Requirements for regulatory purposes" indicates its status as a demonstration of regulatory compliance, internationally recognised by the sector's stakeholders.
ISO 13485 has been built to be used for any product or service provided by you to the medical device industry; production, but also design, distribution, provision of parts, services, or subcontracting... all stakeholders in the industry fall within the scope of ISO 13485 and can be certified.
This accredited certification is a demonstration of your ability to consistently provide medical devices and services that meet customer and applicable regulatory requirements. It is issued after an audit conducted by an auditor who is competent in your particular sector of activity.
You insure yourself and your partners
Ensure the sustainability of your business
Pre-diagnosis to understand the principles of the audit and maximize your chances of obtaining certification
Your auditor interviews your teams and analyzes your practices and data with regard to the requirements of the standard
Presentation summarizing the audit findings and delivery of the audit report
AFNOR Certification grants your certificate and logo for three years
A monitoring audit is carried out each year and a renewal audit every three years
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This training course will prepare you for designing and controlling a QMS for the medical device industry in accordance with the ISO 13485 standard, ...