Product Lifecycle.
Regulatory and quality considerations through development, change, and post-market activities.
Focus of this practice
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.
The scope of support is agreed around your product, priorities, and available information.
Potential areas of support
Development and design controls
Connect regulatory considerations with development processes and the documentation supporting product decisions.
Risk management
Consider risk-management processes and documentation in the context of ISO 14971 and 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.
When to start
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 togetherA useful starting point
What 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.
Start a conversation
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