Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Shep Bentley

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:
– Therapeutic Goods Administration of Australia
– Brazil’s Agencia Nacional de Vigilancia Sanitaria
– Health Canada
– Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
– The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers

From 01 January 2014 to 31 December 2016, FDA, alongside its international partners, participated in a Medical Device Single Audit Program Pilot. On 29 June 2017, a report was generated summarizing the outcomes of prospective “proof-of-concept” criteria established to confirm the viability of the Medical Device Single Audit Program. The outcomes documented in the Final MDSAP Pilot Report are based on data generated during the three (3) year pilot. Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.

FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. Firms with activities related to the Electronic Product Radiation Control (EPRC) provisions of the Act will continue to be subject to FDA inspections for the EPRC activities. See what the industry has to say about MDSAP audits: “With a Mission to improve the quality of life for patients, prevent progression of chronic diseases, and reduce overall healthcare system costs, ResMed is committed to driving innovation and efficiencies across all aspects of our business. The MDSAP program has allowed us to consolidate the global regulatory assessment process across multiple international locations, reducing internal costs while increasing the overall predictability of these efforts across our global footprint. By minimizing disruption to our business, we can focus on delivering the safest, most effective and technologically advanced products possible. ResMed is proud to participate in a program that is designed to increase efficiencies within our industry while having a positive impact on the cost of global healthcare.”

“Auditors followed published MDSAP audit guidance very closely. We are now preparing to obtain MDSAP certificates for all ISO 13485/CMDCAS locations when MDSAP becomes fully operational in 2017.” “MDSAP allows a reduction in the number of audits conducted resulting in less business disruption. The MDSAP audit was well planned and the well-organized audit expectations allowed us to plan resources ahead of time. Additionally, qualified and competent auditing organizations conduct audits in a consistent manner. The transition from our previous audit cycle to the MDSAP audit program was easy due to the documents available on the MDSAP website. Definitely, more sites will be added to the MDSAP program in 2017 and 2018.”

“MDSAP auditors are experienced and well-trained and apply a task-based audit approach. There is a reduction in the number of audits which brings less business disruption. GREAT web-based materials and guidelines are available to industry.”

Why should you Attend: Today with a single audit, it is possible for a medical device manufacturer to satisfy the quality management system requirements of Australia, Brazil, Canada, Japan and the USA! This is the benefit of the Medical Device Single Audit Program, or MDSAP. However, there are some vital considerations before embarking upon this approach to satisfying the regulators of five major markets. Therefore, with some preparation and insight before the audit, a successful outcome is much more likely. It is essential to the success of this audit to prepare and become fully familiar with the unique advantages that the MDSAP represents, and to allow sufficient time for this preparation. In order to understand the most efficient means of preparing, and to avoid the waste of resources and time that failure to plan costs the organization, the webinar provides a clear and methodical pathway to producing MDSAP-worthy documents and objective evidence of conformity to the desired standards.

Ultimately, with the successful MDSAP audit conducted and completed, the organization may avoid routine inspections by the regulatory agencies of Australia (TGA), Brazil (ANVISA), Canada (HealthCanada/SanteCanada), Japan (MLHW) and the United States of America (FDA). For those organizations operating in the state of California, the Food & Drug Branch (FDB) has also determined that an MDSAP audit would be sufficient to avoid state-level audits. Therefore, the overall value of completing an MDSAP audit is to simplify the process of conformity and compliance, and to enable the organization to control its calendar for audits to ensure that all relevant auditees are present or available to the MDSAP auditor at the necessary time.

Areas Covered in the Session:
– Origin of MDSAP
– Applicability of MDSAP
– Advantages of MDSAP
– Disadvantages of MDSAP
– The decision to proceed with MDSAP or not
– The Future of Medical Device Regulation as relates to MDSAP

Who Will Benefit:
– Corporate Management (Presidents, CEOs, COOs)
– Quality Management (Vice Presidents, Directors, Managers)
– Regulatory Management (Vice Presidents, Directors, Managers)
– Sales & Marketing Management (Vice Presidents, Directors, Managers)

Shep Bentley is the President and Principal Consultant for Bentley Biomedical Consulting, LLC, where he is responsible for regulatory strategies leading to FDA approvals and clearances for digital medical device companies. Shep began his career in 1984 at the Hospital Corporation of America as a research technician, and worked at McGaw Labs in Irvine, responsible for GMPs until 1989, when he joined TOSHIBA America where he managed production of various digital devices. He founded Rising Star, a contract manufacturer for digital medical assemblies in 1993, and sold it in 1997 to Standard Industries in Anaheim. He was a founder of Volcano Therapeutics, Inc. in 2001, which was acquired by Philips in 2015.

For the past fourteen years since 2004 as an independent consultant, Shep has worked to achieve device approvals and clearances from the FDA, and market entry for numerous innovative medical technologies and applications within the European Union, Canada, Brazil and across Asia. He speaks regularly at regulatory conferences, has just co-authored a book on device approval and provides independent consulting for clients of Intertek. He is a graduate of The University of The South, and has studied international literature at the Johannes Gutenberg University in Mainz, Germany. He is a member of AAMI, ASQ, RAPS, TOPRA and on the Program Committee of the Orange County Regulatory Affairs (OCRA) Discussion Group. He has been a featured speaker on the topic of cybersecurity for the past two years at the FDA Annual Meeting, and the Medtech Monday events in California.