Anthony Parise, Product Strategist—Life Sciences, ETQ11.30.18
The Medical Device Single Audit Program (MDSAP) is growing fast, with 3,629 sites now participating, as compared to just 788 at the end of 2017.
Part of this explosive growth stems from the fact that Canada will require manufacturers to comply with MDSAP to sell devices there starting Jan. 1, 2019. What’s more, the U.S. Food and Drug Administration (FDA) has announced it as well, and will be moving to MDSAP within the next few years.
Maintaining business continuity in Canada is one of several advantages MDSAP adopters will have over their competition, but certification still presents significant challenges. One manufacturer has developed a unique approach to managing MDSAP’s complexity, creating an automated solution that’s delivered more than $250,000 in annual savings and has allowed for huge efficiency gains.
MDSAP lets device manufacturers use one audit framework to demonstrate compliance with regulatory requirements in multiple regions, including the United States (FDA), Health Canada, Australia (TVA), Brazil (ANVISA), and Japan (MHLW/PDA).
With a goal of harmonizing audit requirements among participating countries, MDSAP’s underlying structure is based on ISO 13485 for medical devices. Benefits of MDSAP certification include:
Another problem organizations are running into is scheduling enough time between documentation and preparedness review in Stage 1 and official QMS evaluation in Stage 2. Technically, Stage 1 and Stage 2 audits can be combined, but that doesn’t necessarily leave much time to correct identified gaps.
Top priority should be deciding either to stop doing business in Canada—as some smaller manufacturers have despite audit time reductions for those companies—or accelerate MDSAP certification. The supply of certified auditors is limited, and bottlenecks in audit scheduling mean that companies need to get moving quickly to avoid costly delays.
In terms of doing business in Brazil, early adoption will also deliver a greater competitive advantage compared to waiting. That’s because the speed pass line won’t be as large of a benefit once more manufacturers achieve certification.
Since time is essential, it’s clear many manufacturers who opt for MDSAP certification would benefit from having a third-party consultant evaluate their QMS ahead of time. Just as important, companies will want to apply lessons from that test run to all of their processes, or else risk running into similar problems in a different area later.
With the announcement from Health Canada, an ETQ customer with over 10,000 global employees and nearly a dozen global facilities quickly determined the company needed to take action. Like many device manufacturers, Canadian sales represented a large enough portion of their business that the company couldn’t afford to delay MDSAP certification.
However, MDSAP required managing a huge volume of spreadsheets related to regulatory requirements, data collection, and submissions. Not only that, adding MDSAP to their existing internal audit program would mean conducting up to 200 audits every year. The company needed an electronic tracking system that met these current needs while providing flexibility and scalability to support future growth.
The manufacturer turned to its automated QMS to create an audit module integrated with the rest of its quality processes. The team configured custom forms and workflows to set up audits and verify individual standards, audit methods, and auditor qualifications. Building a custom MDSAP application for its QMS delivered significant results for the company such as:
MDSAP certification holds clear advantages for device manufacturers, and the program continues gaining momentum despite challenges and bottlenecks. Like any worthwhile endeavor, reaping the rewards means investing time and resources in preparation. And for those willing to go the extra mile, integrating MDSAP activities within an automated QMS can provide even more significant results.
Anthony Parise is a product strategist for life sciences at ETQ, a Burlington, Mass.-based leading provider of quality, EHS, and compliance management software trusted by some of the world’s strongest companies to secure brand reputation, transform insight into action, and help them focus on what matters most.
Part of this explosive growth stems from the fact that Canada will require manufacturers to comply with MDSAP to sell devices there starting Jan. 1, 2019. What’s more, the U.S. Food and Drug Administration (FDA) has announced it as well, and will be moving to MDSAP within the next few years.
Maintaining business continuity in Canada is one of several advantages MDSAP adopters will have over their competition, but certification still presents significant challenges. One manufacturer has developed a unique approach to managing MDSAP’s complexity, creating an automated solution that’s delivered more than $250,000 in annual savings and has allowed for huge efficiency gains.
MDSAP lets device manufacturers use one audit framework to demonstrate compliance with regulatory requirements in multiple regions, including the United States (FDA), Health Canada, Australia (TVA), Brazil (ANVISA), and Japan (MHLW/PDA).
With a goal of harmonizing audit requirements among participating countries, MDSAP’s underlying structure is based on ISO 13485 for medical devices. Benefits of MDSAP certification include:
- Fewer audits: One MDSAP certificate satisfies requirements for regulatory audits from the five member countries each year, based on the global marketing of products.
- Lower costs: MDSAP minimizes the business disruption associated with multiple episodes of prep, hosting, and post-audit analysis, which can total millions of dollars in staffing costs.
- Streamlined registration: Having to complete fewer audits to register products reduces the record-keeping burden, accelerating time-to-market for new devices.
- Clearer standards: MDSAP’s structure uses a weighted matrix to score each section of the standard. Providing numerical scores instead of major versus minor observations makes MDSAP compliance less subjective and helps manufacturers prioritize follow-up.
- Canada: After feedback from manufacturers facing audit scheduling and certificate delays, Health Canada eased some requirements around the Jan. 1 deadline. If organizations can show evidence of a scheduled MDSAP audit and have an ISO 13485:2016 certificate, they will be able to continue selling products according to existing transition cycles.
- U.S.: The FDA announced plans to adopt the international consensus standard ISO 13485 in place of the current Quality Systems Regulation. The agency will use MDSAP audits, which include scoring based on ISO 13485, to replace the Quality Systems Inspection Technique model. With an action date of April 2019, this should put MDSAP and ISO 13485 certification on every manufacturer’s strategic plan.
- Brazil: ANVISA is giving MDSAP-certified companies priority over non-certified companies, slashing waiting times to register some products from six years to just six months.
Another problem organizations are running into is scheduling enough time between documentation and preparedness review in Stage 1 and official QMS evaluation in Stage 2. Technically, Stage 1 and Stage 2 audits can be combined, but that doesn’t necessarily leave much time to correct identified gaps.
Top priority should be deciding either to stop doing business in Canada—as some smaller manufacturers have despite audit time reductions for those companies—or accelerate MDSAP certification. The supply of certified auditors is limited, and bottlenecks in audit scheduling mean that companies need to get moving quickly to avoid costly delays.
In terms of doing business in Brazil, early adoption will also deliver a greater competitive advantage compared to waiting. That’s because the speed pass line won’t be as large of a benefit once more manufacturers achieve certification.
Since time is essential, it’s clear many manufacturers who opt for MDSAP certification would benefit from having a third-party consultant evaluate their QMS ahead of time. Just as important, companies will want to apply lessons from that test run to all of their processes, or else risk running into similar problems in a different area later.
With the announcement from Health Canada, an ETQ customer with over 10,000 global employees and nearly a dozen global facilities quickly determined the company needed to take action. Like many device manufacturers, Canadian sales represented a large enough portion of their business that the company couldn’t afford to delay MDSAP certification.
However, MDSAP required managing a huge volume of spreadsheets related to regulatory requirements, data collection, and submissions. Not only that, adding MDSAP to their existing internal audit program would mean conducting up to 200 audits every year. The company needed an electronic tracking system that met these current needs while providing flexibility and scalability to support future growth.
The manufacturer turned to its automated QMS to create an audit module integrated with the rest of its quality processes. The team configured custom forms and workflows to set up audits and verify individual standards, audit methods, and auditor qualifications. Building a custom MDSAP application for its QMS delivered significant results for the company such as:
- Faster time to market: The company saw a 92 percent reduction in waiting period for registering certain product types, also reducing average closing time up to 50 percent.
- Improved staffing efficiency: The manufacturer was able to save $71,400 annually on external auditor resources, also eliminating a full-time contractor position dedicated to administration of paper-based audits. The equivalent of an additional full-time employee’s salary was saved through greater efficiency in audit scheduling and file execution.
- Return on investment (ROI): The project’s payback period was 5.6 months, with total benefits of over $253,000 annually. The project has delivered an ROI of 315 percent.
MDSAP certification holds clear advantages for device manufacturers, and the program continues gaining momentum despite challenges and bottlenecks. Like any worthwhile endeavor, reaping the rewards means investing time and resources in preparation. And for those willing to go the extra mile, integrating MDSAP activities within an automated QMS can provide even more significant results.
Anthony Parise is a product strategist for life sciences at ETQ, a Burlington, Mass.-based leading provider of quality, EHS, and compliance management software trusted by some of the world’s strongest companies to secure brand reputation, transform insight into action, and help them focus on what matters most.