Medical Device Single Audit Program (MDSAP) Offerings

MDSAP Programs Listing

MDSAP is here to stay – now that regulators from five different countries have mutually accepted it while respecting the sovereignty of each authority.  Canada had indicated it will only accept the MDSAP certificate as evidence of compliance with the QMS requirements starting January 1^st. 2019; however that requirements has been relaxed now.

The time to understand and move forward with MDSAP is here; and we are ready to support you on your journey. With six training programs, auditing, coaching, and help with updating your QMS / SOPs – you can avail of a complete package of services. Here is more information on our training programs.

1. 1. 1. MDSAP Overview for Managers and Business Leaders (3-4 hours): A high-level view of how to obtain an MDSAP certificate, aligning it with your business and market strategy, timing, cost, audit durations, its fit with ISO 13485, and regulatory agencies. You will also get a sense of the audit process, and the essentials to prepare / structure your organization to move forward. Along the way, gain insight into the intersection of all functional groups with MDSAP.
      2. MDSAP for Internal Auditors (2-3 days): This training will build your skills and knowhow to “conduct” in-house audits to the requirements of MDSAP. Benefit from deep dives into MDSAP, the links to ISO 13485, and regulations from Australia, Brazil, Canada, Japan, and the USA. Extensive interactive / role-play exercises cover the seven processes, creation of checklists, identifying non-conformities, grading method, conducting interviews, audits, running opening / closing meetings, and writing reports.
      3. Preparing to face the MDSAP Audit (2 days): This program prepares you to “face” the audit with confidence. Understand the requirements of MDSAP for each of the seven processes, and country specific requirements. Learn how to handle tough questions from the auditor through case studies and role-play with your coach. Get valuable tips on how to prepare your documentation and evidence to present during the audit.
      4. MDSAP for Design Engineers / Professionals (1 day): Focused on the essentials of the Design and Development Process, this training explores in-depth: the requirements and expectations for D&D together with links to other processes, ISO 13485, and country specific regulations.
      5. MDSAP Essentials for Manufacturing / Process Engineers, Associates, and Services (1 day): This program is focused on Production and Service Controls. It provides extensive coverage of MDSAP requirements on the topic, links to ISO 13485, and country specific regulations.
      6. MDSAP Essentials for Purchasing Professionals (1 day): The Purchasing process is covered in detail with focus on MDSAP requirements, links to other processes, ISO 13485, and country specific regulations. You will also take away valuable tips on Supplier Management.

Custom designed programs available too!  Call us today: (512) 560 8326 or contact us using the form below

NOTE: Pricing depends on the program you choose, degree of customization if any, location, and size of the audience. We will be happy to provide a quote after understanding your specific needs.

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