A Quality Management System (QMS) is the backbone of the design, production, and management of medical devices. It is now mandatory for all medical device manufacturers to have a quality management system (QMS) in compliance with Article 10 of the MDR/IVDR.
Article 10 of both the EU Medical Device Regulation 2017/745 (MDR) and the EU In Vitro Diagnostics Regulation 2017/746 (IVDR) require that all manufacturers set up and use a Quality Management System. Article 10 provides the minimum requirements which should be met by such a QMS; some of which are not indicated within ISO 13485:2016.
Advena offers a variety of services related to the creation, maintenance, and upgrade of QMS, including:
- ISO 13485:2016 compliant QMS, gap analysis, or upgrade.
- MDR/IVDR QMS requirements gap analysis or upgrade.
- MDSAP gap analysis or upgrade.
- Internal audit services.
Advena specialises in the creation medical device quality management systems for all manufacturing and related services to assist you in becoming compliant to the ISO 13485: 2016 standard. Following an initial conference call, we will be able to put together the backbone documentation and processes required for a compliant ISO 13485:2016 QMS. If you already have a compliant QMS, we can suggest how to incorporate requirements of the EU Regulations or MDSAP into your existing procedures.
For those manufacturers of low-risk devices looking to only specifically meet the requirements as listed in Article 10 of the EU Regulations, we also offer a lighter QMS solution. You would then be expected to build on this and develop the appropriate records as you use the QMS.
Manufacturers may also wish to ‘stress test’ their QMS in preparation for an upcoming audit. We can conduct a Documentation Gap Analysis to highlight nonconformities with respect to the standard, or we could perform a more in-depth Internal Audit to test your processes. The Advena gap analysis will evaluate your QMS and assess your level of compliance, identifying any opportunities for improvement, observations or nonconformities when comparing your current QMS to the standard. After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Advena can upgrade your QMS for an agreed fee.
MDSAP
If it’s your intention to access US, Brazilian, Japanese, Australian and/or Canadian markets you will be required to comply with the requirements of the Medical Device Single Audit Program (MDSAP).
The MDSAP program involves a recognised certification body conducting a single regulatory and quality audit of a medical device manufacturer which aims to satisfy that all the relevant requirements for the participating regulatory authorities have been implemented.
At Advena, we have experts who specialise in guiding manufacturers to compliance whether it’s ISO 13485:2016 or with the additional requirements of MDSAP and the first logical step is to perform a gap analysis.
The Advena gap analysis will evaluate your QMS and assess your level of compliance, identifying any gaps, deficiencies or nonconformities when comparing to your current QMS to the standard you wish to achieve.
After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Advena can upgrade your QMS for an agreed fee.
This service is particularly helpful for SME’s and start-up organisations whose depth of resources may not allow for a gap analysis to be conducted internally.
For more information on how Advena can assist with assessing your QMS to either ISO13485:2016 or to include the requirements of MDSAP certification or even to implement a new QMS please contact the Advena team.
