Medical device business uses STREAM® to support product compliance and ISO certification
A medical device business uses STREAM® to track regulatory requirements, product risks, controls and compliance evidence during product development, and to support its ISO certification process.
The story in four lines
Customer
A medical device business
Use Case
Risk and compliance management during medical device product development
What Changed
Structured tracking of regulatory requirements, product risks, controls and compliance evidence using ISO, NIST and SCF references
Outcomes
Greater visibility of design-stage compliance decisions and support for the organisation's ISO certification process
The Challenge
The organisation develops complex medical devices and supporting hardware products and operates across multiple regions and regulated sectors. It needed a structured way to track regulatory requirements, product risks, controls and compliance evidence during product development.
Late identification of compliance gaps can be especially expensive for hardware products, because design changes become harder and more costly once development has progressed.
The Solution
STREAM® supported a risk and compliance management system for medical device development, helping the organisation:
- Track risks and controls with reference to ISO, NIST and SCF methodologies
- Maintain visibility of design-stage compliance decisions
- Bring product risks, controls and compliance evidence into a common structure
Supporting ISO Certification
STREAM® supported the organisation's ISO certification process by providing a structured environment for managing the risks, controls and evidence relevant to certification.
The Impact
- Greater structure and traceability around product compliance during development
- Clearer visibility of design-stage compliance decisions for complex hardware products
- A consistent reference point for ISO, NIST and SCF-aligned risks and controls
- Support for the organisation's ISO certification process
Bring structure to product compliance and certification evidence.
See how STREAM® can support risk and compliance management across product development, with structured tracking of regulatory requirements, controls and evidence.
Acuity Risk Management helps businesses worldwide effectively manage, prioritise and report on their risks to inform strategic decision-making and build long-term resilience.
Its powerful STREAM® platform provides rapid time to value to reassure stakeholders that risks are under control and compliance is maintained with increasingly complex standards and regulations. With STREAM®, Acuity eliminates the guesswork around risk to support strategic decision-making, prioritisation of resources and justification of expenditure to maximise ROI. With customers worldwide, Acuity has proven success supporting customers in highly regulated and targeted industries such as finance, IT, telecommunications, healthcare, defence and government.