Good Manufacturing Practice for Medical Devices

Reading Scientific Services Ltd
Course summary
1 day
695 GBP excl. VAT
Full time
Next available date: Dates available in 2020. Inquire for more information. - Reading

Course description

Good Manufacturing Practice for Medical Devices

The course covers the requirements of the Medical Device Regulatory Standard ISO 13485 and the regulatory framework and documentation required to market a medical device. Those attending will get an understanding of the requirements and documentation required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives, the regulatory system, the marketing of a device and the ISO 13485 Medical Device Standard. Added to this there is an introduction to risk management and the vigilance system. The course is interactive with many practical exercises and discussions.

Suitability - Who should attend?

GMP for medical devices is the perfect course for people who are new to the medical device industry, the diagnostics sector or those working in the pharmaceutical industry where medical device regulations are applied - e.g. for inhalers, pre-filled syringes, infusion bags etc.

Training Course Content

At the end of the course you will:

  • Understand the regulatory framework of medical device manufacture and marketing
  • Understand the ISO standards and how they are used in the approval process
  • Have knowledge of the tools used in risk assessment and vigilance systems

About provider

Reading Scientific Services Ltd

Reading Scientific Services Ltd

As an externally accredited training organisation (IRCA, RSC), you can be confident that by choosing RSSL you will be in safe and experienced hands. Our specialist training courses for the pharmaceutical industry cover a wide range of areas such as...

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Contact info

Reading Scientific Services Ltd

Whiteknights Campus, Pepper Lane
RG6 6LA Reading

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Average rating 5

Based on 1 reviews

Good 'package' of basics you can start with to build your knowledge on medical devices.
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