Medical Technology Regulatory Affairs MSc/PgCert/PgDip

Executive/Part-time

Medical Technology Regulatory Affairs MSs

In today’s competitive and highly regulated healthcare environment, it is essential for companies to bring new products to the market quickly – and to keep them on the market. Excellence in managing regulatory issues within a changing environment is a key strategic advantage to healthcare companies.

Regulatory affairs professionals play an important part in coordinating scientific endeavour with regulatory demands throughout the life of a medical device product from design conception through manufacture to market.

This qualification is delivered in collaboration with TOPRA (The Organisation for Professionals in Regulatory Affairs) combining TOPRA’s long-standing experience and expertise with Cranfield’s strong academic reputation and its links to industry. For the first time, it provides graduate professionals working in medical device regulatory affairs with a recognised way of formalising your skills in the field, giving you an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.

  • Available on a part-time basis only, this qualification is designed to be flexible in order to fit around your current job and responsibilities. 
  • Courses are also available at Diploma and Certificate level, allowing even greater flexibility.
  • Individual modules may be attended as standalone short courses, without the need to register for the full qualification (for professionals with a specific interest).

Watch the MSc course video (YouTube)



Course overview

This part-time Medical Technology Regulatory Affairs MSc course provides working professionals with the opportunity to obtain a formal qualification in the Medical Device Regulation industry. The programme is specifically designed for professionals to help support you to fit study into your working life. Modules are condensed as we appreciate securing time away from the office is challenging and off campus support is available via online facilities and personal tutor support via email and telephone.

This MSc presents a broad view of the regulatory affairs role and provides a detailed insight into current and proposed EU legislation.

Through a collaboration between Cranfield and TOPRA this unique MSc provides graduate professionals working in healthcare regulatory affairs or related areas, with an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.

With this formal qualification, skills will be easier to demonstrate to employers and peers. Employers will benefit through the development of personnel to an increased level of competence and professionalism whilst those involved in recruiting will find it easier to identify proficiency using this gold standard.

The programme will also help you develop a set of transferable skills that will directly meet the requirements of your current or future employer including information technology, written and verbal communications skills, team working, independent research skills, data analysis and critical thinking.

Medical Technology Regulatory Affairs MSc is made up of three components:

  • A formal taught component comprising eight modules
  • Core Principles Integration - Integrating Portfolio
  • Individual Research Project

Individual Project

The individual research project is an integral part of the course. It gives you the chance to apply the skills, knowledge and understanding acquired during the taught phase of the course to a practical problem in regulatory affairs.

The research project will most likely be undertaken in your place of work - benefiting both you and your employer. However you may be able to complete this at Cranfield or possibly at another organisation and we may be able to help you find placements. This element constitutes 40% of the overall mark.

Core Principles Integration

A critical part of the course, the integrating portfolio enables you to effectively apply the theory you have gained from the taught elements of the course to your workplace. This element constitutes 20% of the overall mark

Modules

The formal taught component of this course comprises eight modules covering everything from the main principles of regulatory affairs to regulatory strategies used when taking new products to market. This element constitutes 40% of the overall mark and the marks for each of the modules are obtained through a combination of different written assignments.

Each module is delivered over three days in our dedicated postgraduate teaching facilities at Cranfield University and a maximum of four modules can be studied each year.

For those students who do not wish to complete the full MSc course a Diploma and Certificate level is also available. The Diploma includes eight modules and an integrating portfolio. The Certificate includes six modules.

For even greater flexibility individual modules can be attended as standalone three-day short courses. Please enquire for more details.

Cranfield University campus has excellent transport links and several hotels and accommodation options on site making it a very easy place to attend modules.

Core

  • Principles of European Medical Technology Regulatory Affairs (RA)
    Syllabus

    Module syllabus covers the following topics:

    • Context and structure of new approach directives within the EU legislative framework
    • Role of European Commission, Competent Authorities and Notified Bodies
    • Definitions / Classification of technology and devices including drug / device borderline products
    • Conformity assessment routes and the role of quality management systems (ISO 13485) in the CE marking process
    • Technical Documentation – compilation, content and assessment of compliance with requirements of the directives
    • Demonstration of conformity through pre-clinical bench testing and clinical evaluation
    • Introduction to the central role of risk assessment in regulatory affairs
    • Introduction to other applicable regulations
    • Standards and Common Technical Specs
    • Overview of the European regulatory framework for IVDs
    • Risk Management
    • Authorised representative (Economic Operators).
    Intended learning outcomes

    On successful completion of the module, the student will be able to:

    • Critically evaluate the application of legislation and guidelines to specific medical technologies to be marketed within the European Union (EU) and associated territories
    • Describe the criteria for classifying different types of medical technology and be able to determine the Conformity
    • Assessment route options for the different classes of technology
    • Plan the requirements for a Technical File and a Design Dossier Design a schema for the detailed activities leading to a CE-Mark.
  • Design, Development and Testing of Medical Devices
    Syllabus
    • Control of design and development; input and output requirements and the required documentation using example devices
    • Impact of materials choice
    • Design, verification, validation and testing of medical devices (including software)
    • Applicable legislation, regulatory standards, guidance and other documents (including GXP)
    • Design and manufacture of packaging
    • Labelling including Unique Device Identification
    • Biocompatibility, toxicology
    • Risk management
    • Additive Manufacturing
    • Sterilisation.
    Intended learning outcomes

    On successful completion of the module, the student will be able to: 

    • Give appropriate advice to the medical device team on key regulatory issues affecting the design and manufacturing operations
    • Produce necessary technical documentation within project timeframes
    • Demonstrate critical safety and performance of devices using applicable product standards.
  • Clinical Evaluation of Medical Devices
    Syllabus
    • Outline the clinical research paradigm for medical devices in Europe and USA and the key underlying ethical and statistical methodology
    • Core regulatory requirements relating to appropriate performance of devices
    • Analyse the place of clinical evaluation in risk analysis and risk management of device development and manufacture
    • Requirements for ethics committee approval and IRB approval
    • Notification and pre-approval requirements in Europe and the USA
    • Systematic review in clinical investigation
    • Health technology appraisal systems and reimbursement on clinical evaluation.
    Intended learning outcomes

    On successful completion of the module, the student will be able to: 

    • Understand and assess the need for clinical evaluation including the need to critically evaluate existing literature
    • Understand the methodology and conduct of clinical research
    • Factors that influence the quality of clinical evaluation.
  • Strategic Management of Regulatory Affairs
    Syllabus
    • Roles of the Medical Device Regulatory Affairs Professional in managing the current regulatory systems and strategies for successful global registration
    • Strategic alliances, Mergers and Acquisitions and their impact on the regulatory process including the practice and principles of Due Diligence
    • Product acquisition and divestment and the regulatory implications
    • Business planning - product and portfolio management including the relationship between regulatory strategy and pricing and reimbursement considerations
    • The impact of electronic submissions and electronic document management and communication
    • Introduction to strategic analysis and scenario planning for the global device industry
    • Harmonisation elements and globalization
    • IMDRF.
    Intended learning outcomes

    On successful completion of the module, the student will be able to: 

    • Critically evaluate the factors necessary to establish the role of regulatory affairs within a medical device organization
    • Deploy the skills and competencies required by the regulatory affairs professional in managing a department and the confidence to make recommendations and decisions
    • Critically evaluate the factors required for effective interaction with regulatory agencies and Notified Bodies
    • Devise and defend a Global Regulatory strategy and development programmes required to achieve medical device compliance/approval in
    • Europe, North America, Asia and emerging markets
    • Understand the role of regulatory affairs professionals in due diligence for planned mergers and acquisitions.
  • Medical Technology Vigilance, Post-Market Surveillance and Risk Management
    Syllabus
    • European Regulatory requirements for PMS, including recalls and vigilance
    • Responsibility for PMS: Competent Authorities, Notified Bodies and manufacturers
    • Other Regulatory requirements – eg US MDRs
    • Guidance documents for PMS, including Commission, Notified Body and Competent Authority documents
    • Key elements of PMS – reactive and pro-active
    • Tailoring PMS systems to specific products, including IVDs
    • Principles of ISO 14971 “Application of risk management to medical devices”
    • Requirements of ISO13485, Quality Management Systems standard
    • Feedback of PMS data into the risk management process
    • Exchange of information: PMS databases eg MAUDE and EUDAMED
    • Crisis Management
    • Summary of post-market regulatory activities.
    Intended learning outcomes

    On successful completion of the module, the student will be able to: 

    • Define the requirements and describe the guidance notes for PMS sufficiently well to critically design a PMS system appropriate to defined products
    • Describe the requirements and guidance notes for vigilance sufficient to write and operate a vigilance procedure which would meet regulatory requirements
    • Describe the principles and practice of risk management as set out in ISO 14971 to a level where they can apply it to a complex medical device within the range of the student’s technical competence.
  • US Regulation of Medical Technology
    Syllabus
    • Introduction to US Food, Drug and Cosmetics Act
    • Identify the structure and mission of FDA
    • Device Classification
    • Pre-market Notification
    • Pre-Market Approval
    • Establishment Registration
    • Device listing
    • Quality System Regulation and QSIT
    • Labelling and UDI
    • Medical Device Reporting
    • FDA audits and enforcement powers
    • Combination Products
    • Highlight key differences to the EU system.
    Intended learning outcomes

    On successful completion of the module, the student will be able to: 

    • Demonstrate a thorough understanding of US medical technology regulation by describing the principles of the regulatory system.
    • Devise and plan regulatory strategies to enable launch of medical technology on the US market
    • Describe the alternate pathways to the US medical technology market and the associated requirements, differentiating between exempt, pre-market notification clearance and pre-market approval products
    • Outline the underlying principles and regulatory processes in the US, covering FDA enforcement powers, medical device reporting, quality system regulations, establishment registrations and device listings
    • Describe the principle differences between the US and EU medical technology regulatory systems.
  • Regulatory Strategy Through the Product Lifecycle
    Syllabus
    • Intellectual Property (IP)
    • Commercial responsibilities of regulatory professionals in pricing, technology assessment reimbursement and tenders
    • Own-Brand Labelling
    • Product surveillance, risk management and implications for labelling
    • Environmental issues including Packaging & Packaging Waste Directive, Weee, RoHS etc.
    • Labelling, advertising, promotion; use of the Internet, e-labelling and DTC (Direct to Consumer)
    • Data Privacy & Protection, FOI (Freedom Of Information) and transparency
    • Supply chain management and e-business
    • Product liability issues
    • Business Intelligence
    • The politics of regulation – building effective problem solving, negotiation and lobbying skills.
    Intended learning outcomes

    On successful completion of the module, the student will be able to: 

    • Explain and apply advertising regulations to medical devices in the EU and the USA
    • Critically advise commercial departments on the post market requirements for health technology assessment leading to pricing and reimbursement
    • Demonstrate various environmental and recycling issues by a critical review of the packaging of typical medical technology in the EU market
    • Understand the legal basis for Product Liability, Intellectual Property and Contracts.
  • Special Topics in Medical Devices in the EU
    Syllabus
    • European Regulatory requirements for PMS, including recalls and vigilance
    • Responsibility for PMS: Competent Authorities, Notified Bodies and manufacturers
    • Other Regulatory requirements – e.g. US MDRs
    • Guidance documents for PMS, including Commission, Notified Body and Competent Authority documents
    • Key elements of PMS – reactive and pro-active
    • Tailoring PMS systems to specific products, including IVDs
    • Principles of ISO 14971 “Application of risk management to medical devices”
    • Requirements of ISO13485, Quality Management Systems standard
    • Feedback of PMS data into the risk management process
    • Exchange of information: PMS databases e.g. MAUDE and EUDAMED
    • Crisis Management
    • Summary of post-market regulatory activities

    Intended learning outcomes

    On completion of this module, a student should be able to:

    • Define the requirements and describe the guidance notes for PMS sufficiently well to critically design a PMS system appropriate to defined products
    • Describe the requirements and guidance notes for vigilance sufficient to write and operate a vigilance procedure which would meet regulatory requirements
    • Describe the principles and practice of risk management as set out in ISO 14971 to a level where they can apply it to a complex medical device within the range of the student’s technical competence

Assessment

Modules – combination of written assignments. Core Principles Integration element - written assessment. Individual Research Project - combination of a submitted thesis and oral presentation. The pass mark for all components is 50%.

Start date, duration and location

Start date: The start date is flexible; you can enrol at any time throughout the year

Duration: Part-time MSc - up to three years, Part-time PgCert - two years, Part-time PgDip - two years

Teaching location: Cranfield

Overview

This formal qualification is the ideal way to demonstrate your existing skills to employers and peers, and to enhance your career in regulatory affairs by developing increasing levels of competence and professionalism. It offers flexibility and support for those who wish to train whilst remaining in employment and is the ‘gold standard’ in the field. Delegates gain invaluable access to industry professionals and networking events to help develop their careers.

TOPRA’s involvement in the MSc ensures its relevance and currency in the field. It also means that you will benefit from being taught by a team of external practitioners and well as leading university staff.  

Students come from the UK and the EU and usually have anything from 2 - 25 years experience in the field. This mix provides excellent opportunities for networking and exchange of knowledge.  

There are 15 places available on this course - class sizes are kept relatively small to help create an interactive environment and to ensure each student receives excellent support from our academic team.

Accreditation and partnerships

The course is delivered in partnership with The Organisation for Professionals in Regulatory Affairs. 


Your teaching team

  • Mr Kamal Sehdev
  • Mrs Joan Houghton
  • Dr Jeff Newman

Students benefit from a programme of visiting lecturers from industry, please enquire for speaker information for specific modules.

Facilities and resources

Students benefit from excellent teaching facilities in a professional environment.

Whilst off campus the following services are available to offer you continuous support with your study:

Library Services

The Cranfield Library and Information Service on campus offers an extensive collection of books, journals and as well as access to nearly 200 databases and over 8,500 electronic journals.

Computer Access

There is 24 hour access to a fully networked personal computer centre on site with cutting edge equipment and fast broadband connections.

Distance Learning Support

24 hour distance learning support is provided to all students via ‘Blackboard’, a virtual learning environment to which all students on the course are automatically registered. Blackboard is the primary means of contact by all University staff for information (including course handbooks, timetables and lecture materials). In addition, the Course Director can provide you with email and telephone support, if required.

 


Entry Requirements

A first or second class UK Honours degree, or an equivalent, in a science, business or management subject, preferably with two years’ experience in a relevant role within the healthcare industry. In certain cases a blend of qualifications, motivation and relevant experience will be acceptable.

Available on a part-time basis only the course is specifically designed for industry professionals working within regulatory affairs who would like to train to further their careers.

Membership to TOPRA would be beneficial.

English Language

If you are an international student you will need to provide evidence that you have achieved a satisfactory test result in an English qualification. The minimum standard expected from a number of accepted courses are as follows:

IELTS - 6.5

TOEFL - 92 

Pearson PTE Academic - 65

Cambridge English Scale - 180

Cambridge English: Advanced - C

Cambridge English: Proficiency - C

In addition to these minimum scores you are also expected to achieve a balanced score across all elements of the test. We reserve the right to reject any test score if any one element of the test score is too low.

We can only accept tests taken within two years of your registration date (with the exception of Cambridge English tests which have no expiry date).

Students requiring a Tier 4 (General) visa must ensure they can meet the English language requirements set out by UK Visas and Immigration (UKVI) and we recommend booking a IELTS for UKVI test.

 


Fees

Home EU Student Fees

MSc Part-time - £1,500 *

PgDip Part-time - £1,500 *

PgCert Part-time - £1,500 *

Overseas Fees

MSc Part-time - £1,500 *

PgDip Part-time - £1,500 *

PgCert Part-time - £1,500 *

*

The annual registration fee is quoted above. An additional fee of £1,300 per module is also payable.

Fee notes:

  • The fees outlined apply to all students whose initial date of registration falls on or between 1 August 2016 and 31 July 2017.
  • All students pay the tuition fee set by the University for the full duration of their registration period agreed at their initial registration.
  • A deposit may be payable, depending on your course.
  • Additional fees for extensions to the agreed registration period may be charged and can be found below.
  • Fee eligibility at the Home/EU rate is determined with reference to UK Government regulations. As a guiding principle, EU nationals (including UK) who are ordinarily resident in the EU pay Home/EU tuition fees, all other students (including those from the Channel Islands and Isle of Man) pay Overseas fees.

Funding

Bursaries may be available, however please be aware that funding will, in most cases, only be discussed once you have secured a firm offer of a place on the course. Please contact the Enquiries Office for further details.

Application Process

Online application form. Applicants may be invited to attend for interview. Applicants based outside of the UK may be interviewed either by telephone or video conference.

Career opportunities

The Medical Technology Regulatory Affairs MSc provides graduate professionals working in healthcare regulatory affairs – who have already gained first-hand practical experience of handling regulatory issues – with an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.

Several of our past students have moved into regulatory roles or been promoted within their organisations.

In addition, our course will help you develop a set of transferable skills, such as data analysis and critical thinking that will directly meet the requirements of your current or future employer.

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