Consultancy

If you are intending to supply or sell medical devices there is lot of legislation that you need to follow. The regulatory environment is constantly changing and it is essential to understand what is applicable to your business and products and how that might change in the future. We offer consultancy services in all aspects of business involving medical devices and can help from first principles in market assessment, right through the product lifecycle. 

For more information contact the office.

Training

If you already manufacture, sell or distribute devices or are intending to do so, then this training is for you. The training includes several modules, the first is an introduction to the complex area of Medical Devices.  If you have or are considering adding medical devices to your product portfolio, it is essential to understand the regulations around you as an organisation as well as those around the product you are selling. Regulations and product requirements to sell and distribute devices from the UK are being changed and pushed back constantly at the moment. The course will go into different roles in the distribution channel and the obligations in each of these roles.

There are six further training modules that provide an overview into the rules and regulations to ensure compliance when manufacturing and distributing medical devices. The industry is highly regulated and there are constant changes in dates and goalposts with regards to how devices are labelled and marked and placed on the market.  The regulations vary with types and classification of devices.

Each module is a half day session, contact the office for bespoke options.

Training Modules

INTRODUCTION TO MEDICAL DEVICES

An introductory level course ideal for anyone who wants some high level knowledge about devices, regulations and requirements.

• What is a Medical Device?
• Classifications of Medical Devices
• Placing a device on the Market
• Regulations
• UK Responsible Person

In addition to the introduction above, we also offer courses which go into more depth for specific parts of the industry.

CLASSIFICATION OF MEDICAL DEVICES

• Specific requirements for different classifications
• Multiple classifications on a product
• Impact of different classifications on the business
• Upcoming changes to classifications 

ACTORS AND ECONOMIC OPERATORS

• The roles, responsibilities and obligations of Manufacturers, Importers and Distributors
• The UK responsible person and the EU Rep
• Notified Bodies, critical services and suppliers, and Industry Associations

LEGISLATION

• A detailed look at getting devices on the market; the legislation, processes and procedures that you need to follow
• Moving from MDD to MDR
• Emerging UK Legislation following Brexit

VIGILANCE

One of the key changes between the MDD and the MDR is the requirement to publish regular vigilance reports. The vigilance requirements on importers and distributors are becoming more clearly defined with further changes expected in the coming months. This session takes a look at what the regulators and Notified Bodies will be expecting from device manufacturers,  importers and distributors.

QMS AND TECHNICAL FILES

• What are they?
• Why do we need them? 
• What should they contain?
• ISO 13485 Certification ……….. or is there another way? 

IS MY AESTHETIC OR COSMETIC PRODUCT NOW A MEDICAL DEVICE?

• “Devices with no medical purpose”
• If your product is affected, it will be illegal to sell it in certain markets in the future without it being registered.
• Regulations, Classifications and Implications.

Upcoming Courses

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