Medical Device Regulatory Framework
EU legislation & history
MDR objectives & economic operators
Intended purpose & classification
Harmonized standards & guidances
Label & instructions for use
UDI & EUDAMED
Intro on clinical evidence & post-market activities
Intro on technical documentation
QMS (MDR – ISO13485)
Management responsability
Resources management
Product realization
Measurement, analysis and improvement
Certification
Tactical implementation
Medical Device lifecycle
D&D Outline stages of the design and development process
QRM : Links between ISO 13485 and ISO 14971
QRM: Outline stages of the risk management process
Tactical implementation.
Product requirements – from idea to product
GSPR checklist – purpose & examples
Concept of harmonized standards.
How to leverage standards to show complaince with GSPR
GSPR requiring specific attention
Sub contractor selection – obtain what you want
Dealing with suppliers and subcontractors.
Clinical evaluation process
Changes brought by MDR
Clinical evidence – what does it include, from marketing survey to RCT ?
Clinical investigation & ISO14155
Clinical investigations tactics
Guidances & GSPR
Application to my product
[We advise to follow Workshop 6 also, because both are take in account together by the notified body]
Requirements for PMS, PMCF, PSUR, SSCP
Defining a PMS/PMCF plan
Balancing between pre and post-market clinical studies.
[We advise to follow Workshop 5 also, because both are take in account together by the notified body]
Training session content #1: Data Privacy
Introduction of Data Privacy principles and Personal Data
Legal aspects to take into account when collecting healthcare-related data
Review of the principles, rights and procedures
How to manage patient request?
Role of the Data Protection Officer
Comparison between GDPR and main other international laws (HIPAA, PIPEDA etc.)
Rules of international Data Transfers
Impacts of Data Privacy for the collect and processing of personal data
Key steps to follow for a successful data privacy implementation program
Risks and penalties under non-compliance
Training session content #2: Data Security
Usual security challenges faced by healthcare organizations
Overview of Good security practices
How to limit data hacking, protect IT systems and make it “user friendly”
Data safety and confidentiality: how to minimize the risk of intrusion and identification?
How to manage a Data Breach under current data protection law?
Classification rules (MDR, IEC62304, FDA)
Special attention points for risk analysis
Harmonized standards & guidances
IEC62304
Design & Development
Release and deployment
Post Market requirements
Control and change control
The map of stakeholders. Competent authorities vs Notified Bodies vs Certification Bodies. Respective roles and involvement in Conformity Assessment
Comparaison with US stakeholders map
Current Notified Body landscape: the demand vs offer problem
Tactics when dealing with Notified Bodies
European Notified body representatives invited during the WS
US: deeper dive
Australia, Canada
UK (Brexit): the specific impacts
Swiss (Swixit): the specific impacts
China: overview
MDSAP: principles. Interesting or not? When?
