GMP Training Video for Medical Devices

What’s so special about a Medical Device?

The term ‘Medical Device’ covers a wide range of products ranging from a medical thermometer to the most sophisticated life support systems, such as implants and computers, to diagnose, prevent or treat disease, or other conditions.

‘What's so special about a Medical Device?’ is a 20 minute training DVD that focuses on the basic principles of current Good Manufacturing Practice (cGMP) associated with the manufacture of a medical device, as well as the component parts, sub-assemblies and materials used in the manufacture of a medical device.

It takes into account Regulatory Guidelines 21 CFR 820 and ISO 13485.

The DVD is designed especially for the induction of new employees, and as a refresher for experienced personnel.

By working through this programme, participants will understand:

• that a simple first aid plaster requires the same level of care during manufacture as, say, a blood glucose monitor ...and why.
• the importance of documentation and record keeping.
• the importance of following Standard Operating Procedures (SOPs), without any deviation.
• the importance of personal hygiene and good housekeeping.
• the meaning of process controls.
• the responsibility of maintenance personnel, working in manufacturing areas, to avoid compromising the quality of the product.

Above all:

• the significance of personal accountability and patient welfare.

The DVD is widely used in the UK and the USA, including 10 of the top 40 medical device manufacturers worldwide:

• Johnson & Johnson
• 3M
• Fresenius
• Terumo
• Cardinal Health
• Smith & Nephew
• Becton, Dickenson
• Abbott Laboratories
• St. Judes Medical
• Dentsply