Quality managment system consulting
A medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.
ISO 13485 is a stand-alone QMS standard, derived from the
internationally recognized and accepted ISO 9000 quality
management standard series. While ISO 13485 is based
on the ISO 9001 process model concepts of Plan, Do, Check, Act, it
is designed for regulatory compliance. Thus it is more prescriptive
in nature and requires a more thoroughly documented quality
management system.
ISO 13485 was written to support medical device manufacturers in
designing quality management systems that establish and maintain
the effectiveness of their processes. It ensures the consistent design,
development, production, installation, delivery through to disposal of
medical devices that are safe for their intended purpose.
The Medical Device Single Audit Program (MDSAP) is an international
initiative led by Regulatory Authorities (RA) to implement a program
where Auditing Organizations (AO) can conduct a single audit of a
medical device manufacturer that would be accepted by multiple
regulators to address QMS/GMP requirements.
Health Canada announced in December 2015 the requirement for
medical device manufacturers to transition from CMDCAS to MDSAP
to place devices into Canada. From January 1, 2019 Health Canada
will only accept MDSAP for manufacturers who market their devices
in Canada, hence, manufacturers will need to transition from
ISO 13485 Certification issued by a CMDCAS recognized registrar
to MDSAP Certification issued by an AO.
We will set up procedures for the following:
- Document and records control
- Training on regulatory requirements and internal procedures
- Design and development
- Risk management
- Software development (if applicable)
- Supplier evaluation
- Control of measurement equipment
- MDSAP consulting
