ISO 13485:2016 Requirements

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.

GMED North America, Inc.

ISO 13485:2016 Requirements - 2-day Virtual Classroom Training; May 12-13, 2026.

Schedule (Eastern Time): 9:00 am - 5:00 pmAbout the trainingWith over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used. Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published on February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance. GMED North America’s “ISO 13485:2016 Requirements” training course will provide the attendee with a general understanding of the concepts of the ISO 13485:2016 standard and how the requirements impact the day-to-day operations of organizations in the Medical Device industry. You will learn about the clauses of ISO 13485:2016 in detail, and also participate in group exercises and in-depth discussions. Attendees successfully completing this course receive a Certification of Completion from GMED North America. Sign up today and join our intensive 2-day course on the ISO 13485:2016 Requirements. Acquire a solid foundation so that you and your team are prepared to tackle through practical cases, working sessions, discussions with our expert trainer, and the challenges of the standard. REQUIRED LEVELA prior review of the ISO 13485:2016 standard is recommended for this course. Who Should Attend:<ul><li>Medical Device Manufacturers: Regulatory Affairs Managers, Quality Managers, Person in Charge of Regulatory Compliance</li><li>Internal and External Auditors</li><li>ISO Coordinators/Management Representatives</li><li>Any individual requiring a working knowledge and understanding of ISO 13485:2016 standard</li></ul> Learning Objectives:<ul><li>Describe the new concepts and definitions introduced by ISO 13485:2016</li><li>Learn the key changes and regulatory requirements introduced in the 2016 version of ISO 13485</li><li>Understand the importance of gap assessment and transition timelines</li><li>Cross-referencing between the former versions of ISO 13485 ( ISO 13485:2003 and NF EN ISO 13485:2012) and ISO 13485:2016 for a smooth transition</li></ul> Educational Resources<ul><li>Presentations</li><li>Practical working sessions</li><li>Course evaluation</li></ul> Program:<ul><li>The regulatory context surrounding the revision of the ISO 13485 standard;</li><li>The areas of increased emphasis on ISO 13485:2016 (Risk management, software validation, etc.);</li><li>The additions, key requirements, and evolutions of the ISO 13485 standard:</li><li>A Clause by Clause review of the changes in the 2016 version of ISO 13485:</li><li>Clause 3: Definitions</li><li>Clause 4: General requirements introduced by ISO 13485:2016</li><li>Clause 5: Management Responsibility</li><li>Clause 6: Resource Management</li><li>Clause 7: Product Realization</li><li>Clause 8: Measurement, Analysis, and Improvement</li><li>Practical working sessions</li><li>Group workshop</li><li>Course Evaluation</li><li>Summary and Discussion with the trainer</li></ul>

ISO 13485:2016 Requirements

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ISO 13485:2016 Requirements

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