World Wide Quality and Regulatory for Medical Devices

About this course

Discover the similarities and differences between the most sought after regulatory markets after EU and USA

Understand how to plan and manage market access to the major markets outside of EU and USA

Assess the impact on your Clinical, Technical and Quality Management systems in order to gain successful entry

Establish the pitfalls and serious issues that may affect your product to market strategy

Evaluate the internal and external resources required in order to achieve successful product registration.

Diverging Global Regulations for medical devices are creating difficulty for manufacturers to gain assurance of market entry and as a result is leading to uncertainty for people involved in developing and implementing the product to market process. Our worldwide regulatory series has been created in order to deal with the specific demands of global quality and regulatory professionals in order for them to plan and manage these critical activities.

Our week-long series begins with a simple overview of the medical device markets comparing regulatory and quality systems and outlining where likely regulatory and quality plans are likely to differ. We outline the typical failures experienced by our clients and by our own people where underestimating either the regulatory pathway or the inspection process has caused significant resource impact on a companies product to market process.

Throughout the week we then deal with specific markets concentrating on the Clinical requirements, pre-submission, inspection and post market activities typical of that market and highlight critical considerations for implantable, combinations, IVD’s and software – The product areas that may create differences

Course outline

Day 1 – Introduction to worldwide medical device quality and regulatory requirements - Yvonne Middlefell / James Pink

• The role of the International Medical Device Regulatory Forum
• Similarities and differences between world-wide markets – A Review by continent
• How to keep up to date with global regulatory requirements
• Medical Device definitions and potential classification issues / Product areas
• Classification systems and conformity assessment pathways
• Clinical Data requirements
• Technical Documentation Requirements – Similarities and differences

Day 2 - The submission Process - Yvonne Middlefell / James Pink

• Unique Device Identification
• Reimbursement strategies
• Importing, Distribution and legal manufacturer representation
• Other Regulatory requirements demanded by worldwide regulatory agencies - Quality Systems - Single audit programmes and International Memoranda of understandings / agreements - Post Market Responsibilities – A critical review of similarities and differences

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

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  James Pink
  Medical Devices, Vice President
  

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

What you've said

This is a new course for NSF-DBA and we will soon be able to provide you with feedback from our Medical Device programme.