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 is therefore a key strategic advantage to healthcare companies.

At a glance

  • Start dateFlexible start date; enrol at any time
  • DurationPart-time MSc – up to three years, Part-time PgCert – two years, Part-time PgDip – two years
  • DeliveryTaught modules 40%, Integrated portfolio 20%, Individual research project 40%
  • QualificationMSc, PgCert, PgDip
  • Study typeExecutive / Part-time

Who is it for?

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. 

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.

Why this course?

This part-time course provides graduate professionals working in healthcare regulatory affairs or related areas, who have already gained first-hand practical experience of handling regulatory issues, with the opportunity to obtain a formal qualification. You will gain an advanced theoretical understanding of the processes and practices central to medical device regulatory affairs.

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, a broad view of the regulatory affairs role and provides a detailed insight into current and proposed EU legislation. 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. It 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.

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.

Your teaching team

Students benefit from a programme of visiting lecturers from industry.


Course details

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. Class sizes are kept relatively small to help create an interactive environment and to ensure each student receives excellent support from our academic team.

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.

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

Assessment

Taught modules 40%, Integrated portfolio 20%, Individual research project 40%

Core modules

Principles of European Medical Technology Regulatory Affairs (RA)

Module Leader
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

Module Leader
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

Module Leader
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

Module Leader
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

Module Leader
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

Module Leader
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

Module Leader
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

Module Leader
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

Fees and funding


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.
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 Opportunities

Places on this course are usually self-funded or sponsored by your company. Please contact the Enquiries Office for further information. Please note that a formal offer of a place on this course must have been received before consideration can be given for funding.

To help students find and secure appropriate funding, we have created a funding finder where you can search for suitable sources of funding by filtering the results to suit your needs. 

Visit the funding finder.

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.

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.

Your career

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.

Applying

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

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