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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
ISO 13485 is a harmonized standard used to meet the regulatory and legislative requirements necessary to provide medical devices and associated services in Europe.
Purpose
Certifying your system to ISO 13485 shows that you are committed to meeting both customer and regulatory requirements in an effective and systematic way.
Manufacturers of medical devices are responsible for ensuring that the product is safe and fit for its intended use. By implementing a quality management system in accordance with the standard, you fulfil the applicable parts of the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
With RISE Certification as a certification body, you get a partner to grow with. Our auditors are located throughout the country and to ensure competence, we have a mix of employees and contracted auditors.
Method
An independent accredited agreement with specific requirements for quality system certification is ensured through an initial audit, annual follow-up audits and recertification audits every three years.
Deliveries
When the organization meets the requirements for medical device quality system certification according to ISO 13485:2016, a certificate can be issued.