Person Responsible for Regulatory Compliance Training

  • Overview
  • Qualifications
  • Tutors
  • Modules
  • Q&A

NSF International launched the Person Responsible for Regulatory Compliance program in collaboration with the Sheffield Hallam University in September 2013.

We are the first organization to recognize the future demands of the changing regulatory and quality landscape. Proposed revisions of the medical and IVD directives advocate that businesses have a Regulatory Compliance Professional in key QA/RA roles.

The course consists of eight modules designed to address the knowledge requirements for Regulatory Compliance Professionals as described in the draft EU medical device regulations. In particular, the modules cover the regulatory compliance requirements associated with the design, manufacture, release and post-market surveillance of medical devices in Europe.

The modules provide practical, face-to-face tuition in master’s degree-level detail to prepare candidates for the challenging and ever-growing role of acting as the person responsible for regulatory compliance in today’s medical device industry. This course uniquely focuses on the knowledge and practical decision-making exercises necessary to build skills and confidence for the person responsible for regulatory compliance role. Sufficient time and depth are provided to grow regulatory compliance professionals to be the best they can be and to prepare the candidates for the role ahead, not just the assessment process.

We recognize that busy professionals cannot always commit to a rigid eight-module schedule over a 21 month period, so we provide the flexibility to fit your training into your work life; you can start and finish whenever you choose and take as many or as few modules as you wish over a period that suits you.

Qualifications

NSF offers a comprehensive, flexible modular study program that leads to either module certification through NSF and the Chartered Quality Institute or to gaining a qualification -- postgraduate certification (PgCert), postgraduate diploma (PgDip) or Master of Science (MSc) -- through Sheffield Hallam University.

Certificate

The certificate is ideal for quality professionals looking to gain further qualification or recognition in their profession. You must complete four modules and perform satisfactorily in the assessments for each to be eligible to apply for the postgraduate certificate with Sheffield Hallam University.

Diploma

To register for the postgraduate diploma, delegates must generally attend all modules (although exemptions on the basis of prior learning can be granted). Delegates who perform satisfactorily in all assessments may then sit the diploma examinations. If successful, they will be awarded the university diploma in QA/RA and gain membership in the CQI (MCQI) and of the Chartered Quality Institute (CQI).

MSc

Holders of the postgraduate diploma who have attained a sufficient standard overall may proceed to the MSc by undertaking a supervised, industrially relevant project on a topic approved by the course director. Candidates are required to satisfy the board of examiners in a presentation of their project dissertation and in an oral examination. Project proposals shall normally be submitted within six months of completing the diploma course.

Tutors

Our tutors are highly qualified and internationally acclaimed QA/RA experts with regulatory backgrounds or experience within the medical device industry. We are committed to providing the highest quality training and education through delivery of our Person Responsible for Regulatory Compliance program.

Modules

The Person Responsible for Regulatory Compliance training program consists of eight modules, which cover the following topics:

Medical Device Regulatory Frameworks

  • Structure of the European regulatory system for medical devices
  • Device risk classification
  • Developing regulatory strategy
  • Understanding regulatory science
  • Regulatory submission management
  • The regulatory organization and processes

Medical Device Risk Management, Design, Development and Product Validation

  • Design control regulations
  • Fundamentals of a design process
  • Design planning, managing and reviewing
  • Risk management in medical devices
  • Standards and product specific testing
  • Device verification and validation
  • Managing design change

Medical Device Clinical Evaluation

  • Regulatory requirements for clinical evaluation
  • Planning clinical investigations
  • The clinical evaluation plan
  • Clinical evaluation steps
  • Post-market clinical follow-up
  • Clinical evaluation reports
  • Clinical benefit over risk determination

Medical Device Conformity Assessment-Preparing and Managing Technical Documentation

  • Regulatory requirements for technical documentation
  • IMDRF STED format
  • Writing and reviewing technical documentation
  • Interacting with development, validation, manufacturing and supplier functions to obtain technical documentation
  • Managing technical documentation
  • Managing regulatory agreements with third parties

Medical Device Conformity Assessment - Implementing and Managing Quality Management System Processes

  • Quality system requirements
  • Quality management systems and process interactions
  • Top management responsibilities
  • Resource management processes
  • Product realization processes
  • Process validation
  • Supplier controls
  • Corrective and preventive action

Medical Device Post-Market Surveillance and Vigilance

  • Regulatory requirements for product surveillance and vigilance
  • Post-market surveillance plans
  • Complaints and investigation management
  • Adverse event reporting
  • Managing field notifications, recalls and corrections
  • Liaising with multiple regulatory agencies

Working With Competent Authorities, Notified Bodies and Other Regulatory Stakeholders

  • Communicating with notified bodies and competent authorities
  • Scientific and technical briefings
  • Regulatory agency inspections
  • Responding to regulatory agency action
  • Remediation strategies for EU, US and ROW actions
  • International working groups

Research Project in Practice

  • Planning major QARA projects
  • Managing projects
  • Literature review techniques
  • Managing research
  • Writing up findings and conclusions
  • Research techniques

Q&A

What is a Person Responsible for Regulatory Compliance?

The European Commission recently issued proposed legislation for manufacturers in the medical device industry to have a medical device Person Responsible for Regulatory Compliance in regulatory affairs and quality assurance.

This specification in the proposed legislation parallels a similar requirement in the pharmaceutical industry and certain medical device regulations under German law.

Based on this information, NSF and Sheffield Hallam University have collaborated to produce a pathway to becoming a medical device Person Responsible for Regulatory Compliance. The program consists of three options, the postgraduate certificate, postgraduate diploma and a medical device Regulatory Compliance Professional status with or without an MSc.

NSF offers a series of professional training courses to address the demands for a medical device regulatory compliance professional responsible for the most critical phases of your product lifecycle.

Why NSF?

NSF has over 25 years of experience delivering university-accredited training to the medical device and pharmaceutical industry. We have a deep knowledge of and a wealth of extensive experience in the challenges and solutions faced by medical device professionals on a day-to-day basis. Our professional medical device courses are designed to address these challenges by offering practical solutions and support to the modern day quality and regulatory compliance professional.

Upcoming Courses & Webinars

In Person Responsible for Regulatory Compliance Training
  • “I felt the course was delivered excellently. My knowledge base for regulatory frameworks was relatively zero entering the course and I feel all subjects were explained brilliantly.”Darren Hall / Swann Morton
  • “The tutor really knows his stuff. Enjoyed working through medical device directives; found it really helpful.”Wilson Kennedy / Hospira
  • “Great delivery of the course and clear handouts. I enjoyed the practical work as it emphasized the principles in the slides with real-life examples.”Eleanor MacKinnon / Reckitt Benckiser
  • “This was extremely beneficial with a good mix of presentation and hands-on workshops. Good discussion throughout and trainer was very knowledgeable and open to questions, particularly useful to use real life examples.”Sarah Edwards / Reckitt Benckiser
  • “Excellent delivery of content. Interactive and transferable content and activities.”Adam Townsley / Reckitt Benckiser
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