Medical Device Training

The requirements of ISO 13485:2016, worked through the day-to-day tasks of a medical device manufacturer. For teams that will set up, maintain or prepare the quality system for an audit.

• Structure of the standard and its relation to the MDR and Turkish (TİTCK) regulations
• Documentation, control of records and management responsibility
• Design and development, purchasing, production and traceability
• Measurement, analysis, nonconformity and improvement

Planning, conducting and reporting internal audits of an ISO 13485 quality management system. Audit principles follow the guidance of ISO 19011.

• Audit programme, audit plan and auditor competence
• Preparing checklists, interviewing and collecting evidence
• Writing and grading nonconformities
• Audit report and follow-up of findings

The corrective and preventive action process from a practitioner’s point of view: from defining the problem to verifying that the action was effective.

• CAPA inputs: complaints, nonconformities, audit findings and trend data
• Root cause analysis techniques: 5 Whys and the fishbone (Ishikawa) diagram
• Action plan, ownership and deadlines
• Verifying effectiveness and presenting CAPA records in an audit

Assessing and recording changes to design, processes, suppliers and labelling under the quality system and the MDR.

• Control of design and process changes in ISO 13485
• Impact of a change on risk, verification and validation
• Substantial changes that must be notified to the notified body
• Updating the technical documentation and labelling

The structure of the EU Medical Device Regulation (MDR) and the core obligations it places on manufacturers. For teams new to the MDR or moving over from the MDD.

• Scope, definitions and the obligations of economic operators
• Classification rules (Annex VIII) and conformity assessment routes
• General safety and performance requirements (Annex I) and technical documentation (Annexes II–III)
• Person responsible for regulatory compliance (PRRC), UDI and EUDAMED

Setting up the post-market surveillance (PMS) system and preparing the reports the MDR requires.

• PMS plan and collection of post-market data (Articles 83–84)
• PMS report for class I devices (Article 85)
• Periodic safety update report (PSUR) for class IIa, IIb and III devices (Article 86) and how often it is updated
• Linking PMS output to risk management, clinical evaluation and PMCF

Setting up and documenting the risk management process across the device life cycle in line with ISO 14971:2019.

• Risk management plan and criteria for risk acceptability
• Hazard identification, risk estimation and risk evaluation
• Risk control measures, evaluation of residual risk and benefit-risk analysis
• Keeping the risk management file current with production and post-production information

Validation of production processes whose output cannot be verified by subsequent monitoring or measurement (ISO 13485 clause 7.5.6).

• Identifying the processes that need validation, and the validation master plan
• Installation, operational and performance qualification (IQ, OQ, PQ)
• Protocols, acceptance criteria and reports
• Revalidation and assessment of changes

Classification, monitoring and operation of the cleanrooms used in medical device manufacturing.

• Particle classification under ISO 14644-1 and comparison with EU GMP Annex 1 grades
• Air changes, pressure differentials and airflow patterns
• Environmental monitoring: particles and microbiology
• Gowning, cleaning and disinfection, entry and exit rules

Requirements for the development, validation and routine control of an ethylene oxide sterilisation process for medical devices.

• Defining product and packaging families, process definition
• Microbiological and physical performance qualification, biological indicators
• Routine monitoring, parametric release and revalidation
• Ethylene oxide residuals (ISO 10993-7)

Validation of the sterile barrier system and the packaging system for terminally sterilised medical devices.

• ISO 11607-1: requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2: validation of forming, sealing and assembly processes
• Seal strength and package integrity testing
• Shelf life through accelerated ageing, and transport testing