AI as a solution Is covered and responded to by ISO 13485 for medical devices when applying practical solutions in regulatory demands and options in AI (no matter if it is a training or broader scope of regular activities).
New EU IVD regulation has become obligation/mandatory in 2022, and it represents QMS applied specifically to medical devices.
For example, when we talk about simulators, clinicians can help a lot in the way of defining:
I) which tools and services they need and for which activities are they used
Pseudonymisation scenario (from 1-6); Key roles - Reducing the amount of data Safeguards in the data processing Information security built into the product (software functions) Pseudonymization Encryption (backup)
The basic scenario for data identification
Counter (monotonous)
- Random Number Generator (RNG)
- Irreversible hash function
- Message authentification code (secret key)
- Symmetric encryption (pseudonymization & retrieval)
Service (SaaS)
- Including penetration testing Product
- d / s code analysis
- technical documentation of the product Process (QMS, PLM) Data reference model - GDPR / HIPAA (Health Insurance Portability and Accountability Act)
II) what type of patients needs help ASAP (according to clinical status and picture - maybe we can create signals for a different type of patients (signal has greater impact factor and it is easier to communicate with it). Image recognition should stay core sources for communication between interested parties.
Key processes for data manipulation (signals or image recognition) :
- Life cycle management (LCM)
- Project management (PM)
- Risk management (RM)
- Development (D)
- Implementation (I)
- Support (S)
- Scenario analysis (SA)
Quality Assurance (QA) <≠≠> Quality Control (QC)
III) simulators can build a database for interested parties (i.e. insurance companies) to expand insurance policy and procedure while offering an innovative type of services in future
- Insurance and reinsurance policies
- Hedging against fatal risks
- New GDPR procedures
- Cyber Security Act (in force from 2021-06-19)
- NIS Directive
- E-Health (Germany)
=> Problematic application of agile methods
IV) simulators will increase the success of treatment methods and offer the best options for medical drugs and supplements on the market (it will be some AI consultancy for pharma stores)
Software and hardware development
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