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Mana Piravogi
Tjänsteansvarig Medicinteknik (ISO 13485), Revisor Medicinteknik (ISO 13485) och Kvalitet (ISO 9001)
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Medical device management system certification - ISO 13485
Do you manufacture or distribute medical devices in Europe? If so, you must comply with the MDR and IVDR. RISE certifies your management system to ISO 13485 – an accredited route to regulatory compliance that gives you credibility with authorities, customers and partners.
Purpose
ISO 13485 is the international standard for quality management systems in the medical device industry. Certification demonstrates that you work in a systematic and structured manner to meet both customer and regulatory requirements. It confirms that your processes are controlled, traceable and quality-assured, which instils confidence in your entire way of working and contributes to the high quality of what you deliver.
Manufacturers of medical devices are responsible for ensuring that the product is safe and suitable for its intended use. By implementing a quality management system in accordance with the standard, you comply with the relevant parts of the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).
Benefits of certifying your management system:
- Ensures that you comply with the relevant provisions of the MDR (2017/745) and the IVDR (2017/746)
- Increases confidence among authorities, customers and partners
- Creates clear processes that reduce risks and improve product quality
- Facilitates market access within the EU and globally
- Demonstrates that you take responsibility for patient safety and quality
Method
See the description of the RISE certification process for management systems.
Why get certified by RISE?
Our audits are characterised by innovative thinking and a constructive, open dialogue that provides you with new perspectives, contributes to the development of your business and builds greater trust among your customers. At the same time, you benefit from a reliable and stable service accredited by SWEDAC, backed by many years of experience and expertise within the organisation.
With RISE as your certification body, you gain a partner to grow with. We also offer certification of management systems for quality, the environment and occupational health and safety, as well as a wide range of other certification services covering management systems, products, companies and individuals. RISE can provide a comprehensive solution for you in this field.
Contact us to find out more!