Medical Device Training and Education

  • Overview
  • Medical Devices Qualified Person (EU)
  • Accredited Medical Device Diploma
  • Benefits
  • Why Work With NSF?
  • Experts
  • Success Stories

NSF Health Sciences Medical Devices provides international quality and regulatory training courses, as well as professional qualifications.  These courses are delivered both at our location and yours.  Module topics include understanding the U.S. FDA 510K, PMA, IDE and European CE marking (93/42/EEC, 90/385/EEC and 98/79/EEC), medical device risk management (ISO 14971), and design control and quality system implementation (21 CFR Part 820 and ISO 13485).

Our regulatory science courses cover medical device clinical evaluation (ISO 14155) and biological evaluation (ISO 10993) with popular courses such as Post-Market Surveillance and Medical Device Lead Auditor.

NSF offers flexible, modular and professionally accredited training delivered by industry experts. We provide:

  • Company-wide quality and regulatory awareness modules for U.S. and CE marking
  • Professional certificates and post-graduate qualifications in quality assurance and regulatory affairs
  • Custom training
  • Flexible program of modular-based training courses delivered at our site or yours leading to end-of-module certification
  • Global footprint with local resources in the U.S., Europe and Asia
  • Professional development for quality and regulatory professionals
  • Auditing and inspection training
  • Study days enabling you to upgrade your knowledge by listening to the most experienced people in public health policy, medical device law, medical device science, quality assurance and regulatory affairs   

For more information about NSF Medical Devices training and education in the U.S., email medicaldevices@nsf.org or call +1 202.822.1850.

For more information about NSF Medical Devices training and education in Europe, email eudevices@nsf.org or call +44 1143 600 868.

Medical Devices Qualified Person (EU)

NSF’s Medical Device Qualified Person (QP) program is run in collaboration with Sheffield Hallam University. We have extensive experience delivering university-accredited training to the medical device and pharmaceutical industries. Because our experienced trainers are experts in their fields, you benefit from content that is relevant and presentations that are engaging.

Comprising of a series of eight modules over one to two years, this course has been carefully designed to meet the requirements for theoretical training as detailed in the draft European Medical Devices regulations replacing Directive 93/42/EEC and the Active Implantable Medical Device Directive 90/385/EC. You can attend specific classes or the entire series.

Module 1: Regulatory Frameworks

  • Understanding EU Medical Device CE Marking
  • Implementing EU Medical Device CE Marking
  • Advanced EU Medical Device CE Marking

Module 2: Design, Risk and Product Validation

  • Understanding Design Control for Medical Devices
  • Implementing Design Control for Medical Devices
  • Understanding Risk Management – IS014971 for Medical Devices
  • Understanding Product Validation for Medical Devices

Module 3: Clinical Investigation & Evaluation

  • Planning and Conducting Clinical Investigations for Medical Devices
  • Medical Devices Clinical Evaluation – Step by Step
  • Post-Market Clinical Follow up for Medical Devices

Module 4: Technical Documentation

  • The Design History File for Medical Devices
  • Writing Technical Summaries for Medical Devices
  • Technical Files and Design Dossiers for Medical Devices

Module 5: Quality Management Systems

  • Quality System Requirements for Medical Devices
  • Quality System Product Realization Processes & Requirements for Medical Devices
  • Quality System Top Management Processes & Requirements for Medical Devices
  • Quality System Resource Management Processes & Requirements for Medical Devices
  • Quality System CAPA & Improvement Processes & Requirements for Medical Devices
  • Medical Device Process Validation
  • Managing Suppliers within a Quality Management System Framework for Medical Devices

Module 6: Post Market Surveillance & Vigilance

  • Product Surveillance and Vigilance for Medical Devices
  • Field Safety and Product Withdrawal for Medical Devices
  • Post-Market Surveillance for Medical Devices

Module 7: Working with Regulatory Agencies

  • Structure of the Regulatory Agencies for Medical Devices
  • Pre-Market Technical Briefings for Medical Devices
  • Regulatory Agency Enforcement & Remediation for Medical Devices

Module 8: QARA Research Methods & Project Management

  • Research Methods for Medical Devices
  • Medical Device Project Management
  • Qualified Person Role and Responsibilities for Medical Devices

Accredited Medical Device Diploma

NSF’s eight core distance-learning modules provide the knowledge, tools and techniques to manage all aspects of medical device quality management and regulatory affairs. Dedicated instructors combine workbook learning with work-based projects to ensure balance between theory and practice.

We recognize and build on your existing knowledge and experience, for a more efficient engagement.

The diploma, accredited by Sheffield Hallam University in the UK, includes modules for:

  • Medical device regulatory frameworks
  • Medical device risk management design development and product validation
  • Medical device clinical evaluation
  • Medical device conformity assessment – preparing and managing technical documentation
  • Medical device conformity assessment – implementing and managing quality management system processes
  • Medical device post-market surveillance and vigilance
  • Working with competent authorities, notified bodies and other regulatory stakeholders
  • Management and behavioral skills in quality assurance and regulatory affairs

Benefits

NSF regulatory expertise spans from high-risk implants and non-traditional device types (such as gels and injectables) to routine-use and home-use devices (such as drug-delivery systems). NSF subject matter experts cover all therapeutic areas.

Benefits of partnering with NSF for your medical device training include:

  • Training programs that focus on complex technical, regulatory and quality assurance problems related to medical devices.
  • Learning through doing
  • Learning from subject matter experts and industry-leading facilitators
  • Training tailored to your needs, budget and technical capabilities
  • Post-training support throughout your product lifecycle

Why Work With NSF?

The NSF training team ensures the value of your training by providing support from education through the implementation of your real-life projects. NSF delivers:

  • Skills assessment in medical device development and regulatory and quality assurance
  • Customized training at your site that addresses your specific learning needs, technology, people and processes
  • Modular-based training in the fields of product validation, clinical evaluation, regulatory strategy, GxP, drug device combinations, process validation and post-market surveillance

Science-specific courses in biological evaluation, packaging validation, cleaning validation, risk management, clinical investigation, design dossier compilation, drug/device scientific advisory, drug/device combination product regulatory strategy and more

Experts

NSF delivers the highest quality and most user-friendly training experience. Our trainers are both subject matter experts and industry-leading facilitators.

Our training staff includes:

James Pink – Vice President, Europe, NSF Health Sciences Medical Devices

Mr. Pink has 16 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. His industry experience includes managing development and quality assurance programs for orthopedic, cardiovascular, wound and combination products. Mr. Pink has a team of experts based in Europe who have over 20 years’ individual experience in both competent authority and notified body leadership. He has coordinated and presented to EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings as well as EU remediation strategies.

Yvonne Middlefell, RAC, FRAPS − Executive Director, Regulatory Strategy and Clinical Services

Ms. Middlefell leads our European regulatory strategy and clinical services and has extensive experience in global medical device regulatory affairs. She has worked for a number of key multinational corporations including Amersham Nycomed, Eastman Kodak, Bausch & Lomb and a 25-year tenure at Johnson & Johnson. Her RA experience includes developing global regulatory strategies for IVDs, medical devices, OTC products, biologics and pharmaceuticals. Ms. Middlefell has written and filed multiple CE technical files and US 510(k)s for a range of products that include immunoassays, clinical chemistry analyzers, infectious disease products, contact lenses and solutions. In addition, she has successfully managed a full PMA for an IVD U.S. product submission. She was her company’s primary interface with regulatory agencies and industry bodies such as AdvaMed (USA) and EDMA (EU).

Success Stories

Challenge: A global Fortune 500 medical device company with Class III combination products required regulatory strategy and clinical services training.

Solution: NSF Health Sciences Medical Devices was approached by a Fortune 500 medical device organization with locations in the U.S., Europe and Asia. The client required a series of update modules to provide awareness of the EU medical device regulatory requirements aimed specifically at the design organization, global manufacturing and supply chain. NSF Health Sciences worked with the client to create industry- and process-specific modules for delivery to the entire teams. Through a series of workbooks, webinars and workshops at the client’s site, NSF delivered specific training and education to over 500 people in a four-week period.

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