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2-day In-person Seminar

Implementing MDSAP (Medical Device Single Audit Program) for Compliance Success

May 4th & 5th, 2017

Time: 9:00 AM to 6:00 PM

Boston, MA

Venue: Embassy Suites Boston Logan Airport

Director : David R. Dills

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,295.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $3,885.00
      $6,475.00 You Save: $2,590.00 (40%)*
Register now and save $200. (Early Bird)
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    • Until March 31, Early Bird Price: $1,295.00 From April 01 to May 2, Regular Price: $1,495.00
Course "Implementing MDSAP (Medical Device Single Audit Program) for Compliance Success" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
  • Reviewing the most significant changes affecting medical device standards and guidance documents
  • Understanding the MDSAP (goals and strategy)
  • Analyzing the MDSAP main differences with standard auditing
  • Understanding grading of MDSAP non-conformances
  • Assessing MDSAP Audit structure and reporting to regulators
  • More than six Notified Bodies are in the Pilot Program, Office audits and witnessed audits are required (conducted by regulators)
  • And Much More...

Why should you attend:

  • Clear Understanding of MDSAP objectives, approach and the overall process
  • Develop, manage, and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions
  • To promote greater alignment of regulatory approaches and technical requirements
  • To promote consistency, predictability, and transparency of regulatory programs
  • What is MDSAP?
  • How MDSAP Works?
  • How does MDSAP fit with other certifications?
  • MDSAP Status
  • Beneficial to manufacturers of medical devices who are interested in marketing and selling devices in those countries (Regulatory Authorities)
  • Next Steps in 2017 and going forward?

Areas Covered in the Session:

  • International partners that are participating in the MDSAP Pilot include US FDA, Therapeutic Goods Administration of Australia, Brazil's Ag�ncia Nacional de Vigil�ncia Sanit�ria, 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) Program and the European Union (EU) are Official Observers
  • MDSAP Guidance Documents
  • Regulatory Authorities (RA's)
  • Auditing Organizations (AO's)
  • Audit criteria of the MDSAP program will include the requirements of ISO 13485 and the applicable requirements of the participating regulatory authorities
  • MDSAP Processes and Audit Sequence

Who will benefit:

This seminar will provide an overview and in-depth snapshot and a refresh of the MDSAP certification program. Those interested in how to prepare for the MDSAP audit and how to enhance their MDSAP audit system as a valuable regulatory compliance tool will also benefit from this course. Employees or functional areas who will benefit include:

  • Clinical Research Associates
  • Clinical Project Managers
  • Regulatory Affairs Professionals
  • Clinical Investigators and Clinical Research
  • Regulatory Affairs Management
  • Regulatory Affairs Specialists
  • Regulatory Project Leads/SME's
  • QA Auditors
  • Supplier Auditors
  • GxP Auditors
  • Compliance Specialists
  • Clinical Affairs
  • Quality Manager
  • Quality Assurance
  • Production/Operations
  • Consultants

Day 1 Schedule

Lecture 1: MDSAP

  • Introductions and Background
  • Guidance on the MDSAP program and pilot
  • Is the Medical Device Single Audit Program (MDSAP) mandatory?
  • Concepts, principles and interpretation of the MDSAP program
  • Overview of the significant requirements
  • Impact of the audit model on your organization and audits
  • MDSAP Guidance Documents
  • Full details of the MDSAP pilot prior to 2017
  • Pilot started in January 2014 (for 3 years, to Dec 2016)
  • Certification Bodies from participating member states can apply to become AO's
  • Policies, Procedures, Templates and Forms (Policies, procedures and other related documents supporting MDSAP)
  • Audit Procedures and Forms (Procedures and forms supporting Auditing Organization Audits)
  • Assessment Procedures and Forms (Procedures and forms supporting Regulatory Authority assessments)
  • Training Material (Auditing Organization and Regulatory Authority training material)
  • IMDRF/MDSAP WG and GHTF Documents (IMDRF MDSAP WG and GHTF documents supporting the program)
  • What Auditing Organizations can apply to the MDSAP Pilot?
  • MDSAP findings system, including 5-point scoring
  • FDA's "MDSAP Mid-Pilot Report
  • MDSAP Companion Document and other Resources

Lecture 2: Exercise and Recap of Day 1

  • Interactive Discussions
  • Review of MDSAP Auditing Documents and Case Study

Day 2 Schedule

Lecture 1: MDSAP

  • Recap from Day 1
  • Background of MDSAP Program
  • MDSAP Processes and Audit Sequence
  • How can medical device manufacturers participate? How to Participate in the Program?
  • Audit Duration/Structure
  • Grading of Non-Conformances and Nonconformity Grading - Based on GHTF document SG3/N19
  • Report Writing, Certification and submission to Regulators
  • Implications
  • Potential Witness Audits by Regulators
  • Primary differences between your current audit and an audit conducted under MDSAP
  • MDSAP Audit Process Timelines and Audit Time Calculation
  • Regulatory Authorities Oversight of the Auditing Organizations
  • Medical device manufacturers' quality management system can be audited once for potentially five different medical device markets
  • Operational Requirements for Manufacturers and AO After the Audit
  • If MDSAP becomes mandatory for one or more participating countries will manufacturers be expected to be compliant with regulations in a jurisdiction that it does not market?
  • What is the link between the MDSAP Audit Criteria and ISO 13485?
  • Regulator's Acceptance of MDSAP Reports
  • Training and Qualifications of MDSAP Auditors
  • Will the European Union Ever Participate in MDSAP?
  • On December 4, 2015, Health Canada announced its decision to end the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program.
  • From January 2019, Health Canada will only accept MDSAP certificates, which will replace the current CMDCAS requirement.

Lecture 2: Recap of Day 2

  • Interactive Discussions
  • Review of MDSAP Auditing Documents and Case Study

Lecture 3: Debrief/Adjourn

  • Recap of topics and key discussion points and take away message
  • FAQs and latest MDSAP auditing trends
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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

David R. Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

Location: Boston, MA Hotel: Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA

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