CAS HES-SO in Clinical Affairs, Regulatory and Quality for Medical Devices and In-Vitro Diagnostic (CARAQA)

1.0.1 Typical products (incl. apps)

Skim over the key families of MD and IVD product and get a grip of what regulations covers

1.0.2 Interaction with bodies

Who are the key stakeholders , competent authorities, notified bodies, legal manufacturers, contractors ?

1.0.3 Markets, startups, acquisitions

What is the structure of the medtech market, big players, startups feeding big players with innovation, typical product lifecycle ?

1.0.4 Implied activities, stakeholders

Get a grip on product lifecycle, innovation, industrialization, atomization of specialties, contractor market outlook, subcontracting design, subcontracting production

2.1 CE regulation

2.1.1 CE marking, new MDRs, IVDR

Regulatory pathways, regulations in EC, changes of regulation

2.1.2 Classification, MEDDEVs

What makes an MD & and IVD, borderline classification? claims, Meddevs and NB-med

2.1.3 Assessment procedures

How does the Notified Body review a CE file ? what are the steps ? 1st skim on what is the contents of a technical file, where is the focus depending on product class ?

2.1.4 Vigilance & MDR, MEDDEVs

What are the duties of an LM ? how are incidents managed ? what should be reported, FSCA and FSN ?

2.1.5 Technical Files

In depth review of technical files, visit of an actual technical file for a complex product, what are the modules, usefulness of a STED

2.2 US regulation, classification, 510k, PMA

510k vs. PMA, US law, delays, links with QSR, principle of predicate device, product classification codes

2.3 Foreign registrations

Procedure of main secondary important markets Canada, Brazil, China, Thailand, Malaysia, Australia, Russia, Korea, classic deployment strategies

2.4 Regulatory, product & process design

2.4.1 Risk management EN ISO 14971

Principles, risk management plan, tools for risk analysis, identification of Harms, HA vs. FMEA, mitigation, residual risk, links with other processes, update

2.4.2 Sobware lifecycle management EN 62304

Categories of sobware, firmware, apps, servers, classification of sobware, lifecycle management, verification and validation

2.4.3 Sterilization EtO, Steam, Radiation

How to select a sterilization process ? principle of validation, how to validate the key cycles, links with packaging validation ?

2.4.4 Usability EN 62366

Principles of usability engineering, user identification, use cases, formative and summative studies

2.4.5 Electrical & safety compliance EN 60601

Principles of safety of ME products, how to organize testing, planning and content of reports, links with risk management and labeling

2.4.6 Biocompatibility EN ISO 10933-1

Scope of application, various scenarios for organizing assessments, impact on suppliers work, links with cleaning validation, organization of tests with test labs, classic tests, chemical characterization

2.4.7 IFUs, labeling

How to structure the work on IFUs, early alignment with product claims, links with risk management, standards for symbols, specific case of ME

2.4.8 Process validation (incl. SW)

Purposes, difference between US and EU, how to plan QC, master validation plan, how to structure a validation plan. Classic processes : cleaning, welding, marking, sterilization

2.4.9 Controlled environments

Cleanrooms and controlled environments setups used for medical device manufacturing and assembly. Contamination control, monitoring, validation

3.0.1 Architecture and deployment QMS

Process approach, how to map processes, sequence of deployment, scope of coverage of QMS, level of details required, layering of documentation, categories of documents.

3.0.2 Change Management

Impact of installing a QMS in a team of engineers, scientists, business people. Key methods for driving the project and the change of behaviors / aitudes

3.0.3 EN ISO 13485:2016

When is it required? what is a cerBficaBon process? what are the key concepts in the standards? measurability, quality policy and objectives

3.0.4 Quality System RegulaBon (QSR)

Impact of a regulation, areas of similarities, differences with ISO 13485, QSR audits, common sensible points, FDA audit style

3.0.5 Medical Device Single Audit Program (MDSAP)

New approach for limiting audits, applying countries, expectations for the future, organization, challenges

3.0.6 Management SubSys.

Instances, management review, KPIs, objectives

3.0.7 Resources SubSys.

Human resources, job descripBons, organization charts, training plan, training records, material resources, preventive and corrective maintenance, calibration

3.0.8 Design & development SubSys.

Design planning, staged versus linear model, design input, layering, design methods, design reviews, structure of DHF, planning of verifications, handling of changes, design verification, integration of usability, integration of risk management

3.0.9 Purchasing & supplier SubSys.

Subcontracting of design, sourcing of processes, managing suppliers, suppliers classes, qualification criterion, quality agreements, incoming QC, supplier audits

3.0.10 CAPA + NC handling SubSys.

Device Master Record, Device History Record, producBtion planning, routers, batch records, extents for traceability, work instructions, integration of contractors, product releases

3.0.11 Documentation and records Subsys.

Tools for managing documentaBon, control process, releases, categories of documentation, list of records, duraBon of storage, paper vs. electronic

3.0.12 Customer related processes Subsys.

Managing distributors, managing channels, contracts, order processing, good distribution practices, customer complaints handling

4.0.1 Clinical evaluation of MDDs, MEDDEV

Regulatory requirements, clinical strategy, investigation vs. evaluation, clinical planning, structure of CER, sources of data, appraisal, link IFUs, biocompatibility and risk management, conclusions, maintenance

4.0.2 Performance evaluation of IVDs

Strategy of performance evaluation for IVD, new expectations linked with IVDR, biobanks samples, review of data

4.0.3 Statistical design

Methods for dimensioning an evaluation, power of analysis, statistical models

4.0.4 Investigation strategy & organization, MEDDEV

Planning of a clinical investigation, endpoints, CA and EC authorization, IBrochure, protocol, CRF, Informed Consent, GCP, EN ISO 14155

4.0.5 Post-market surveillance (PMS & PMCF), MEDDEV

Integration of PMS with CER, planning of Post Market Clinical Follow-up, conditional CE marking / market access, protocols and reports