Complete medical device compliance essentials package
Your focused path to MDR/IVDR biological evaluation and risk management
This streamlined bundle offers the newest ISO 10993-1:2025 biological evaluation standard, paired with ISO 14971:2019 and ISO/TR 24971:2020 for effective risk management implementation, covering the core regulatory essentials for medical device safety and compliance.
What’s included
- ISO 10993-1:2025 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
Features lifecycle-based evaluation aligned with ISO 14971 and updated chemical and biological guidance. - ISO 14971:2019 Application of risk management to medical devices.
Globally recognized for identifying and controlling risks throughout the device lifecycle. - ISO/TR 24971:2020 Guidance on the application of ISO 14971.
Practical support, examples, and templates to implement risk management effectively.
Complete medical device compliance essentials package
Complete medical device compliance essentials package
pub200993
CHF
557
Complete medical device compliance essentials package10% discount
Digital version (PDF), English
Complete medical device compliance essentials packageCHF 619pub200993CHF 557Convert Swiss francs (CHF) to your currency
Who should use this package?
- Medical device manufacturers focusing on biological evaluation and risk management
- Regulatory affairs and quality assurance teams developing compliance documentation
- Startups and innovators prioritizing essential biological safety and risk frameworks
- Consultants advising on MDR/IVDR biological evaluation and risk strategies
Key benefits
- Complete risk-based compliance
Integrates biological safety evaluation with a structured risk management process and practical guidance. - Lifecycle coverage
Supports compliance from concept and design through development, market launch, and post-market surveillance, ensuring continuous risk control. - Practical implementation support
ISO/TR 24971 provides real-world examples and clarifications that make ISO 14971 easier to apply, reducing complexity for regulatory teams.
Package content
- ISO 10993-1:2025Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation …
- ISO 14971:2019Medical devices — Application of risk management to medical devices
- ISO/TR 24971:2020Medical devices — Guidance on the application of ISO 14971
For complete regulatory compliance, we strongly recommend adding ISO 13485:2016, the cornerstone medical devices quality management system standard.
⬇⬇⬇
Published
Medical devices — Quality management systems — Requirements for regulatory purposes