The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be complied with. The Regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market medical devices that are safe and fit for their intended purpose. A medical device manufacturer’s quality management system (QMS) is the foundation for maintaining Regulatory compliance, driving improvement, effectiveness and achieving stakeholder confidence in the manufacturer and their products.
Revised in March 2016, ISO 13485:2016, Medical Devices – Quality Management Systems, is an internationally agreed standard that sets out the requirements for a QMS specific to the medical device industry. The Medical Devices - Quality Management system is designed to be used by organizations throughout the life cycle of a device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services. Hence, implementing and maintaining a QMS is a crucial part of Regulatory compliance for the markets worldwide.
Freyr has extensive global expertise in establishing quality systems compliant with ISO 13485, FDA 21 CFR part 820 Quality System Regulation and other global QMS requirements (i.e. EU Medical Device Directives, Health Canada Medical Device Regulations etc.). In cases of new market entry, Freyr establishes procedures for Regulatory compliance tailored as per the health authority requirements and device manufacturer’s requirements in the target region.
- ISO 13485 consulting and implementation for medical device manufacturers
- Developing a detailed quality plan to implement Medical Devices - Quality Management System, tailored to your company-specific requirements
- Performing pre-assessment audits prior to notified body or registrar certification audits
- Evaluation of your system to ensure your risk assessment and decision-making measures are robust
- Pre-production QMS and Internal audit training for eventual compliance with ISO 13485 and FDA QSR
- Medical device gap, internal, pre-certification and supplier QMS audits
- Qualified team of experts with hands-on experience on QMS requirements
- Vast experience in providing training on Regulatory requirements and internal procedures
- Document and records control
- Internal quality system audits
- Ensures that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485
- Determines conformity or nonconformity of your QMS to ISO 13485:2016 requirements by a systematic and independent process