This module aims to provide students with an introduction to Quality Management and an understanding of setting up a basic QMS and its implementation. It also aims to provide the students with an understanding of the requirement for a quality management system and how to design this quality system under the 21 CFR 820 or ISO13485 headings.

1. Describe the evolution of Quality Management SystemsincludingtheFutureofQuality;Quality4.0

2. Describe a basic QMS and its componentsaswellasQualityManagementsystemsinadigitalage

3. Explain the application and requirements of a QMS as prescribed by 21CFR 820(andintegrationofISO13485:2016asconsensusstandard)andwithENISO13485:2016

4. ExplaintheapplicationandrequirementsofongoingandfutureregulatorybodylegislativeprogramsalignedwithmeetingindustryneedsforQuality4.0

5. Describe the integration of operational excellence methods; Lean and Six Sigma with quality to implement and achieve continuous quality improvement in the MedTech industry

6. Illustrate the audit requirements of a QMS and how to deal with auditors.
7. Understand how to apply ethics and scientific integrity to professional practice.
8. Describeskillsetforthefuturequalityengineersinthesmartfactory;thebarriers,enablers,components,andsmartdigitaltechnologiesinvolvedinQuality4.0deployment

This module aims to provide students with an introduction to and a fundamental understanding of current and upcoming EU legislation as it applies to medical devices and to provide students with an understanding of the EU classification system and potential regulatory pathways for placing medical devices on the market in the EU. It also aims to provide the students with an understanding of the utilisation of standards and guidance documents (MEDDEVs, NBOGs and NBMEDS).

1. Describe the evolution of current legislation and reasons for upcoming revised legislation
2. Classify a medical device under EU requirements
3. Analyse key guidance documents
4. Define an appropriate regulatory pathway for a number of device classifications and associated conformity assessment routes
5. Make change control assessments for common change types
6. Identify the key documents required in technical documentation to support an EU regulatory submission
7. Analyse the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority
8. Describe the basics of ISO 13485:2016, PMS Requirements and Vigilance Requirements

This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to an organisation and the tools required by an effective auditor. In addition, it also introduces corrective and preventive action, non conformance reporting and ongoing compliance.

1. Interpret and explain the relevance of auditing as a means of monitoring the production of safe and effective medtech products in a GMP environment.
2. Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing
3. Source, interpret and apply GMP principles to different case scenarios
4. Role play in a multidisciplinary team of auditors within a GMP environment
5. Critique the performance of a systematic and independent examination of the effectiveness of a quality system
6. Identify, assess and analyse breaches of GMP and recommend appropriate corrective and preventive actions
7. Evaluate non conformance statements and understand the non conformance management process

This module aims to provide students with an introduction to and a fundamental understanding of current US legislation as it applies to medical devices and to provide students with an understanding of the US FDA classification system and potential regulatory pathways for placing medical devices on the market in the US. It also aims to provide the students with an understanding of the utilisation of standards and FDA guidance documents.

1. Describe the evolution of current legislation
2. Classify a medical device under US requirements
3. Analyse key guidance documents and consensus standards and key FDA medical device databases
4. Define an appropriate regulatory pathway for a number of device classifications
5. Make change control assessments for common change types
6. Identify the key documents required in technical documentation to support a US regulatory submission
7. Evaluate how to interact effectively with FDA agents/reviewers
8. Evaluate the basics of US QSRs, PMS Requirements and Vigilance Requirements and navigate the US FDA MAUDE database

This module will enable students to understand the role of Risk assessment through the design process and product lifecycle.

1. Analyse the concept of Risk Management
2. Describe a basic Risk management system and its components
3. Explain the application and requirements of Design & Risk Management under 21CFR 820
4. Explain the application and requirements of Design & Risk Management under ISO14971
5. Describe the risk management tools used to help manage risk in the product lifecycle

This module introduces the regulatory requirement for calibration and validation within a GMP environment, their benefits to an organisation and the tools required for effective implementation This module will prepare students to undertake different validation roles and will equip the student to complete many validation activities within their organisation. The impetus for the development of this module has emerged from industry needs and the course content has been designed to meet this industry need. This module covers the core aspects of interpreting and/or setting quality characteristics and their verification through appropriate calibrated Inspection, Measurement and Testing processes. The module traces the metrological requirements from quality characteristics through instrument selection, evaluation and on-going calibration so that the student is fully aware of the purpose and operation of a good measurement management system.

1. Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.
2. Describe the various metrological requirements from quality characteristics through instrument selection, evaluation and ongoing calibration
3. Outline the properties of a good measurement management system and how it links to validation
4. Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture
5. Critique risk analysis and evaluation and how it relates validation
6. Source and interpret the industry standard guidelines in use for validation within a GMP environment.
7. Outline elements of validation documentation and understand the regulatory requirements and the use of risk management tools in making regulatory decisions.