1 Preface Introduction... 13

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1 1 Preface Introduction Legal Requirements Approach to determining the legal implications Software as a medical device Intended purpose Normal Use Medical device Accessories Legal Requirements for medical devices European medical device law General responsibilities of the manufacturers General safety and performance requirements for software Clinical and performance evaluation of software Software traceability The national legal framework for medical devices in Germany Requirements from other fields of law Copyright Data protection law Advertising in Health Care Act and Act against Unfair Competition Liability law Contractual liability Non-contractual liability product and manufacturer s liability Outsourced processes The road to certification of medical software Medical software in the market Jurisdiction of the notified bodies and national authorities Peculiarities of markets outside the EU Example: Market approval and operation of medical devices in the US

2 Requirements for market approval of medical devices in the US Requirements for the operation of medical devices in the US Proof of product safety Approach to determining international requirements Medical software from the idea to the finished product Product idea Market requirements Compatibility and operability Efficiency, user groups and decision makers Requirements for installation and support Functional requirements Product related regulatory strategy Development of Medical Software Specification of the overall system Specification of the software subsystem Specification of the hardware subsystem Viewpoints in requirements Types of requirements Requirements step by step Principles Usability System architecture/specification of the software components Detailed software design Implementation Risk management General Procedure Risk analysis Risk assessment Risk control Implementation and proof of effectiveness Assessment of the remaining risk Subsequent phases Verification Verification in the language of IEC Verification versus validation Aspects Reviews and inspections Examination by execution

3 Testing levels/test approaches Validation Delimitation Terminology Definition Procedure Traceability Definition Necessity Benefit Implementation The development process Introduction, constraints Standards requirements for the development process Planning the activities before their realization Level of detail of the activities is depending on the safety contribution of the software Design input before design output Mandatory Documentation Change management Possible development processes Factors affecting the selection and design of development processes Cascading process Iterative/incremental processes Agile processes Other best practices in software development and their manifestation in medical software Using tools/tool validation Continuous Integration Test automation Using an ALM tool The benefit of standards Background on standardization Standards on producing conformity with the legal requirements Process standards Software life cycle Interfaces with quality and risk management How big may a software unit be? Requirements for software reliability

4 5.3.2 Quality management Approach to implementing the quality management system Approach in monitoring by internal audits and system analysis Changes in the 2016 version of the EN ISO standard Risk management Risk considerations in IT networks Usability Information security Clinical IT risk management Product standards Electrical medical devices Health software Background on IEC Requirements of IEC Standards with additional area of application Clinical and performance evaluation Index of standards and guidelines Harmonized European standards for medical devices and invitro diagnostic medical devices European standards International standards and technical reports FDA Guidance documents Prospects Future factors which will affect the European legal framework The future role of standards Notified bodies from partner of the manufacturers to the long arm of the authorities Future standards projects regarding medical software Abbreviations/acronyms References and web links References Web links Annex Questions for determining the legal implications Stakeholders with influence on the legal implications Conformity assessment procedure of the European regulations

5 9.4 Classification according to the European MDR Acknowledgement