Medical Devices

Training and Education

At NSF Health Sciences, our approach to learning is ‘learning through doing with experts at your side’. Our training solutions are highly interactive and based on real problems and scenarios within the medical device industry. Many training providers focus on the requirements; NSF Health Sciences, on the other hand, focuses on how to meet the requirements within your business and throughout the product lifecycle.

Courses Offered:

• 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

How We Can Help You via In-House Bespoke Courses

We can bring any of our courses to you, either at your premises or at a venue local to you. You can decide whether you would like the ‘off the peg’ courses or bespoke versions adapted to your particular products and company profile.
Additionally, we can help your company with in-house training conferences on topics such as the following:

• Planning your regulatory pathway to a specific market (e.g. Europe, USA, Canada, Asia)
• Review of your design, risk management and product validation strategies
• update on the latest regulatory interpretations and actions that can slow product release
• Review your processes and provide critical benchmarking against competitors or industry leaders
• Design, implement and review technical processes: biological safety, GMP, process control

How We Can Help You via In-House Regulatory Awareness Events

With the regulatory environment becoming ever-tougher in the wake of new technologies, regulatory science initiatives and public concern, it is essential that your company understands the applicable regulatory requirements.

With this in mind, we can provide whole company regulatory awareness events at whatever level of detail you require, from an executive overview lasting a couple of hours to in-depth studies lasting one or more days.

Upcoming Courses (We run courses at various locations worldwide, please enquire for further details)