The Benefits of MDSAP Acreditation
While there are approval routes that don’t require your devices to be developed and manufactured under an ISO 13485 quality management system, the benefits of this speak for themselves in terms of ensuring compliance and product safety, as well as timely approval. But if you're developing a new device for multiple country launch or already marketing products and want to expand in to a new market the additional regulatory submissions required and approvals process can be daunting and cost prohibitive.
MDSAP (Medical Device Single Audit Program) is the result of more than five years of work by regulatory bodies from Australia, Brazil, Canada, Japan and the US. Based on ISO 13485:2016, MDSAP is an audit program that allows for a single regulatory audit of a medical device manufacturer´s quality management system to satisfy the requirements of multiple regulatory jurisdictions.
The objectives of the MDSAP are to:
- Develop and implement a single audit program that satisfies the needs of several regulatory jurisdictions.
- Improve alignment of regulatory approaches and technical requirements.
- Improve consistency, predictability and transparency of regulatory programs.
Being certified with MDSAP means that an authorised auditing organisation will conduct a single audit of a medical device manufacturer, sharing the results across the participating countries and this potentially negates the need to host several Regulatory authority specific audits over the course of their audit cycles. A successful audit demonstrates compliance with the requirements of the Regulatory Authorities in the specified countries.
The advantages for manufacturers include the following:
- Less audits – since one audit covers the regulatory requirements for all participating countries.
- Audits are scheduled and planned – akin to Notified Bodies in the EU, but unlike the individual audits involving regulatory authorities of the participating countries.
- Technical requirements are aligned between the participating countries.
- There are no surprises – the requirements and audit process are defined and publicly available from the FDA website in the MDSAP Companion Document.
Future proof your market expansion and select a manufacturing partner with MDSAP acreditation.
Mi3 conforms to ISO 13485 through our MDSAP accreditation.
This is great news if we manufacture the products you sell in Australia, Brazil, Canada, Japan and the US as it will potentially increase the speed at which devices can be brought to market or existing devices changed.
Alternatively, if you are currently marketing in Europe, the US and Canada for example, adding Brazil to your intended markets will become easier as you can potentially provide evidence of good manufacturing practice from the one broad audit, which Mi3 have successfully undertaken year-on-year since first achieving our certificate in July 2018
Chosing a contract manufacturer for your medical device is a critical part of the development process and securing your route to market. Ensure you maximise your market potential and ROI by selecting a partner with MDSAP acreditation.
If you'd like to discuss how Mi3 with our MDSAP certification and wide ranging technical expertise in device design, moulding, extrusion, assembly, packaging and sterilisation can help your business achieve success globally contact us today.