Medical Device Single Audit Program (MDSAP) for Manufacturers

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Medical Device Single Audit Program (MDSAP) for Manufacturers 2-day training session; Sept 27-28, 2021.

About this event

About the training

MDSAP should be considered as a strategic asset for organizations based globally, if they export or intend to export medical devices to participating countries.

The program allows an MDSAP 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.

The program is beyond the pilot program and is now running full speed starting up to replace the normal structure audit.

The countries which are using the MDSAP reports and certificates are Australia, Brazil, Canada, Japan, and the USA.

Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) and Republic of Korea’s Ministry of Food and Drug Safety are now Affiliate Members and World Health Organization and European Union are Official Observers to the MDSAP Program.

REQUIRED LEVEL

The requirements are based on ISO 13485, so a basic understanding and knowledge of the standard are beneficial.

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Keywords:  European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Electrical Safety (IEC 60601-1), Medical Device Electrical Safety, ISO 14971:2007, IEC 62366-1:2015), MDSAP, Medical Device Audit, Medical Device Single Audit Program (MDSAP).

WHO SHOULD ATTEND

  • Management Representatives,
  • MDSAP Implementation Teams,
  • Internal Auditors
  • Others who would like to learn the MDSAP auditing process for management systems based on ISO 13485 using MDSAP Audit Model.

The number of participants is maximized to fifteen to provide a stimulating and practical working environment.

LEARNING OBJECTIVES

  • Acquire the knowledge and develop the skills required to be prepared to support an efficient and successful MDSAP audit within your organization
  • Understand how the MDSAP program works and how it is different from the ISO 13485 through its country-specific regulatory audit approach, the grading and handling of the nonconformities, and the handling of the audit report
  • Understand MDSAP Audit Model and Audit Trail
  • Help your organization to assess and adapt your QMS processes with the MDSAP requirements for the jurisdictions where your products are marketed, to be prepared to support an efficient and successful MDSAP by your selected Auditing Organization

EDUCATIONAL RESOURCES

  • Presentations
  • Practical working sessions
  • Course evaluation

PROGRAM:

DAY 1 & 2

  • MDSAP Program: MDSAP fundamentals, principles and approach of the program, regulatory requirements covered by the program
  • The 7 MDSAP Processes structure and audit tasks, differences with the traditional ISO 13485 audit, linkage between the processes and tasks
  • Application for MDSAP audit: initial certification audit (different phases) and audit cycle, audit situation: audit plan (selection of the tasks, defining the audit scope), non-conformity grading, audit report
  • Quizzes all along the training

Note GMED North America retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.

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Organizer GMED North America, Inc.

Organizer of Medical Device Single Audit Program (MDSAP) for Manufacturers

 GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459).

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC).

 

GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016. 

 

Established in 1994, GMED is fully owned by LNE (e.1901), a State owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint stock company (SAS) within the LNE group. 

 

GMED’s success and high level of performance rely first and foremost on a strong and dedicated team of individuals trained at the highest level of the current evaluation and auditing methods to provide the best certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities. 

 

With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market in your target markets.

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