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by Jon Powell
The Medical Device Single Audit Programme (MDSAP) is starting to gain acceptance in the medical device industry. The outcome of more than five years of work by regulatory bodies from Australia, Brazil, Canada, Japan and the US, MDSAP allows a recognised auditing organisation to conduct a single audit of a medical device manufacturer, sharing the results across the participating countries.
This is a great step forward for companies who market in multiple territories. A single audit from the auditing organisation can now be used to check your systems for compliance with requirements from the five participating regulatory bodies alongside requirements derived from ISO 13485. This will potentially increase the speed at which devices can be brought to market and reduce the burden of hosting multiple audits. For example, if you are currently marketing in Europe, the US and Canada, adding Brazil to your intended markets will become easier as you can potentially provide evidence of good manufacturing practice from the one broad audit.
One of the key areas of focus for a quality team is hosting and preparing for audits. When I was a quality manager for a factory producing consumer healthcare products, audits were always at the front of my mind, whether it was an unannounced audit from our notified body or various regulatory authorities or scheduled internal assessments. In 2017, my team and I hosted more than 20 days of external audits and spent a similar amount of days in preparation. A huge burden on the team and the business.
For some businesses which market – or plan to market – in some or all of the participating countries, the requirements are not new, but the integrated audit approach of MDSAP may seem complex and confusing. Regulators are also starting to respond to the challenges highlighted by industry with the new audits. For example, Health Canada – in the first country to fully transition to MDSAP (by 1 Jan 2019) – has now clarified the transition process.
Here at Cambridge Design Partnership we have simplified the landscape by creating a gap analysis tool which maps the requirements of the MDSAP countries with those from ISO 13485. By comparing them against existing ways of working, gaps in a quality management system become more obvious – allowing them to be addressed. This ensures that embracing MDSAP isn’t just a regulatory check-box exercise but one that helps improve your business.
15 November 2019
Clare Beddoes & Bastiaan De Leeuw, highlight some of the key learnings from this year’s Parenteral Drug Association (PDA) Europe event.
13 November 2019
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