Product Lifecycle.
Regulatory and quality considerations through development, change, and post-market activities.
Continuity as your product evolves.
Market entry is one point in a product’s life. Development decisions, software updates, hardware changes, and information from the field can all require further regulatory and quality work.
Development and design controls
Connect regulatory considerations with development processes and the documentation supporting product decisions.
Risk management
Implement and maintain risk-management processes and documentation in accordance with ISO 14971 throughout the device lifecycle.
Change evaluation
Assess the regulatory implications of hardware and software changes, including effects on existing documentation and market authorizations.
Post-market support
Review post-market responsibilities and the regulatory work associated with product maintenance, surveillance, and field actions.
Understand the implications before the next change.
The work may focus on a specific update or provide continuity across a product program. The starting point is the change, the affected markets, and the documentation already in place.
How we work togetherWhat to bring
to the first discussion.
- Product history and current market status
- Description of the proposed change
- Existing design and risk documentation
A brief, non-confidential overview is enough to begin. Detailed documents can be discussed once the engagement arrangements are agreed.
Discuss your regulatory or quality needs.
Tell us about your product, your priorities, and the question ahead. A brief, non-confidential overview is enough to begin.
Contact Crossroads