Regulatory Strategy - Practitioner Course

About this course

The European Medical Devices Directives address the methods required in order to place active implantable, general and in-vitro diagnostic medical devices within Europe. Understanding these requirements requires an in-depth knowledge of the regulations, which are often difficult to interpret and apply at an organisational and product level.

This course aims to prepare you with the insights and ‘quick routes’ to understanding, interpreting and applying the requirements, providing you with a clear knowledge of the European Medical Devices Directives 93/42/EEC, 90/385/EEC and 98/79/EEC and how to implement these as a ‘practitioner’ within your organisation.

What you will learn

• Medical device classification methods, rules and algorithms
• The basis of risk management and the essential principles of safety driving the medical device regulatory frameworks
• Essential medical device processes, GMP and quality management systems
• Methods of demonstrating appropriate design validation and the importance of standards

Clinical strategy planning – literature, investigations and evaluation Medical device conformity assessment pathways and the options often taken by new start-ups, major global device organisations and those with budget constraints – this includes private/own-brand labelling

• Regulatory strategy and project planning fundamentals
• Pre-market and post-market responsibilities for medical device manufacturers
• The role of authorised representatives or overseas agents in the pre-market and post-market phases of the regulatory lifecycle
• The changes to the European Medical Devices Directives
• The conformity assessment process for low/medium/high risk, novel and borderline medical devices and the differences between agency interaction
• The documentation requirements for registration, pre-market submission, on-market and post-market surveillance

Who should attend

People involved in:

• Management
• Regulatory affairs
• Quality assurance
• Clinical evaluation
• Post-market surveillance and vigilance

Course outline

Day 1 – The objectives are to:

• Explain the medical device classification methods, rules and algorithms – the risk-based approach
• Describe regulatory agency decision making for classification borderlines
• Explain the basis of risk management and the essential principles of safety driving the medical device regulatory frameworks
• Describe the essential medical device processes, GMP and quality management systems required to address product quality assurance and identify the methods of ensuring technical documentation is generated to support the achievement of safety and efficacy
• Describe the methods of demonstrating appropriate design validation and the importance of standards
• Simulate typical situations in which your knowledge of medical device regulatory requirements will be utilised in your work setting

Day 2 – The objectives are to:

• Explain clinical strategy planning – literature, investigations and evaluation
• Explain medical device conformity assessment pathways and describe the options often taken by new start-ups, major global device organisations and those with budget constraints – this includes private/own-brand labelling
• Explain regulatory strategy and project planning fundamentals
• Simulate the typical project management scenarios a regulatory professional will experience and mentor you through the situations and challenges you will face
• Identify the areas within the regulations that deal with pre-market and post-market responsibilities for medical device manufacturers
• Describe the role of authorised representatives or overseas agents in the pre-market and post-market phases of the regulatory lifecycle

Day 3

AM – We will discuss:

• The changes to the European Medical Devices Directives – Study Day (students on the course will attend the first part of the day and meet key leaders in regulatory strategy)

PM – The objectives are to:

• Simulate the conformity assessment process for low/medium/high risk, novel and borderline medical devices and identify the differences between agency interaction
• Describe the documentation requirements for registration, pre-market submission, on-market and post-market surveillance

Venue

AMP Technology Centre, Sheffield, UK

We have selected the Advanced Manufacturing Park (AMP) Technology Centre near Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in healthcare manufacturing technologies and supported by clinical and academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham and Leicester, it is a convenient and accessible location.

The AMP has been designed to accommodate a range of manufacturing related activities, from the work of fledgling engineering and technology companies to the University of Sheffield’s collaboration with some of the world’s foremost advanced manufacturing technology businesses, such as Boeing and Rolls Royce.

Hotel Accommodation

We have a block booking of bedrooms at both the Aston Hotel Sheffield and the Holiday Inn Rotherham-Sheffield at a specially negotiated bed and breakfast rate. Hotel reservations should be made directly with the hotel. Please quote ‘NSF’ at the time of booking.

Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure that you are aware of the hotel’s cancellation policy.

Aston Hotel Sheffield, to book please call the hotel on +44 (0) 1142 615690, quoting ‘NSF’.

Holiday Inn Rotherham-Sheffield, to book please call the hotel on +44 (0) 1709 830630, quoting ‘NSF’.

Venue Address and Contact Details

AMP Technology Centre
Advanced Manufacturing Park
Brunel Way
Rotherham
S60 5WG
England

Tel: +44 (0)114 254 1200
Fax: +44 (0)114 254 1201

Tutors

• 

  James Pink
  Medical Devices, Vice President
  

  • [email protected]
  • +44 (0) 1143 600868

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