Medical Device Training and Education
- Benefits of Training
- Why Work With NSF?
- Accredited Medical Device Diploma
We provide training and education for the medical device industry in modular, customized and public training courses. Whether you need to plan a regulatory strategy for a drug/device combination or understand the post-market surveillance requirements for products supplied into Canada, our training and education specialists can help.
We offer short courses, one-day seminars and an industry-leading diploma in quality assurance and regulatory affairs. Our unique market position gives us access to the most up-to-date regulatory interpretations in fields such as drug/device combinations, in vitro diagnostics and high-risk medical devices.
We believe in learning through doing with experts at your side. Our training is highly interactive and based on real problems and scenarios in the medical device and advanced medical products industries. Our courses include:
- Combination Product and Borderline Regulatory Strategies
- Managing Cleanrooms and Sterile Products
- Biological Evaluation and Testing
- Process Validation for Medical Devices
- Clinical Evaluation for Medical Devices
- Implementing Medical Device GMP ISO 13485 Quality Management Systems
- Medical Device Lead Auditor Training
- Risk Management for Medical Devices
- Post-Market Surveillance and Vigilance for Medical Devices
- Managing the Design and Development of Combination Products
Benefits of Training
Benefits of NSF medical devices training include:
- Our training programs focus on the complex scientific, technical, regulatory and quality assurance problems encountered in medical device decision making.
- You'll learn through doing from subject matter experts, industry-leading facilitators and international consultants and specialists.
- We tailor the training to your needs. Our learning and development specialists can determine competency gaps and create targeted training solutions to support your budget and technical capabilities.
- Our regulatory expertise spans many product types from high-risk implants to non-traditional device types (such as gels and injectables) to routine-use and home-use devices (such as drug-delivery systems).
- Our broad network of subject matter experts covers all therapeutic areas.
- We provide post-training support to help you to turn your training and education into essential competence to support your product lifecycle.
Why Work With NSF?
Our unique approach allows us to provide real solutions during training. Not only does our training team educate and provide the necessary knowledge, but we work with you to ensure you can implement your knowledge into your real-life projects. NSF brings the following to you:
- Skills assessment and competency evaluation in medical device development and regulatory and quality assurance roles
- In-house/customized training developed to address your specific learning needs as well as your 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.
Accredited Medical Device Diploma
We provide distance-learning of eight core modules that provide the QA/RA professional with the knowledge, tools and techniques needed to manage all aspects of medical device quality management and regulatory affairs. We combine workbook learning methods with work-based projects to ensure the right balance between theory and practice, all with the support of your own dedicated instructor.
We recognize your prior learning so you can build upon your existing knowledge and experience, rather than repeat it.
The diploma, accredited by Sheffield Hallam University in the UK, has core modules consisting of:
- 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
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