QMS Solution
A Quality Management System (QMS) is critical to an organisation’s ability to develop products and services and successfully deliver those to market to meet customer requirements. In the area of medical device QMS, we are highly experienced in delivering the following QMS solutions:
- Gap analysis for an existing QMS
- Setup Standard Operating Processes and Procedures
- Validation activities such as process validation (IQ/OQ/QP) and validation of software used in production and service provision
- IEC 62304 – medical device software – software life cycle processes
- IEC 62366 – Application of usability engineering to medical devices
- EN 60601-1 – Medical electrical equipment
- Risk assessment (ISO 14971)
- QMS training
QMS Audits
Are you ready for a certification body’s audit?
MDSAP Audit
We help you to prepare for a Medical Device Single Audit (MDSAP). This program allows the conduct of a single regulatory audit of a medical device manufacturer’s QMS, to satisfy the requirements of multiple regulatory jurisdictions.
Countries covered under the MDSAP:
- Australia
- Brazil
- Canada (MDSAP audit is a mandatory requirement for a manufacturer selling medical devices into Canada)
- United States
- Japan
Internal audit
We help you prepare, maintain and execute an Internal Audit program to maintain compliance with ISO 13485, 21CFR820 and other standards. We provide advice on the findings resolution.
Desktop Audit option is available for international clients.
Pre-audit
We perform a pre-audit to simulate a real 3rd party audit (ISO 13485, MDSAP and 21CFR820) to verify company readiness and to provide training on the external audit process.
Desktop Audit option is available for international clients.
Supplier audit
Unsure if your supplier is capable of performing the tasks you need? Or if they comply with regulatory requirements? Don’t get caught short. It’s your responsibility to ensure your supplier is doing the right thing and that they fulfill all your company’s requirements. Let Medical QMS take care of the Supplier Evaluation Process and act on your behalf by performing an audit of your suppliers.
Desktop Audit option is available for international clients.