QMS Consulting
A structured system of procedures and processes encompasses all aspects of medical device quality management (QMS), including design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, and product labeling.
ISO 13485, a standalone quality management system standard, originates from the globally recognized ISO 9000 series. While ISO 13485 shares the process model concepts of Plan, Do, Check, Act with ISO 9001, it primarily serves regulatory compliance and demands a comprehensive, well-documented quality management system.
The development of ISO 13485 aimed to assist medical device manufacturers in creating quality management systems that uphold process effectiveness. This standard guarantees the uniformity of medical device design, development, production, installation, delivery, and disposal, all while ensuring their safety for their intended purpose.
The Medical Device Single Audit Program (MDSAP) represents an international effort, spearheaded by Regulatory Authorities (RA), to establish a framework where Auditing Organizations (AO) can perform a single audit of medical device manufacturers. This audit is recognized by multiple regulators, addressing Quality Management System (QMS) and Good Manufacturing Practice (GMP) requirements. In December 2015, Health Canada mandated that medical device manufacturers shift from CMDCAS to MDSAP to market their products in Canada. As of January 1, 2019, Health Canada exclusively accepts MDSAP for manufacturers marketing their devices in the country, necessitating a transition from ISO 13485 Certification by a CMDCAS-recognized registrar to MDSAP Certification issued by an AO.
Procedures will be established for the following areas:
- Control of documents and records.
- Training in regulatory requirements and internal protocols.
- Design and development processes.
- Management of risks.
- Development of software (if applicable).
- Evaluation of suppliers.
- Oversight of measurement equipment.
- Consultation on MDSAP compliance
How can we help you?
Contact us using the link below and submit your business enquiry.