Regulatory requirements must be translated into appropriate processes, traceable evidence, and verifiable documentation. This applies not only to quality management and technical documentation, but also to conformity assessment, registration, market surveillance, product changes, international market access, and other regulatory requirements for medical devices and IVDs. Even after a product is placed on the market, it must be continuously monitored, findings evaluated, and processes and documentation updated on an ongoing basis. In practice, companies often lack the capacity, specific expertise, or appropriate tools to do this.
What is Regulatory Support?
Regulatory Support assists with the practical implementation of regulatory requirements throughout the product lifecycle within agreed-upon areas of responsibility. The focus is on establishing and refining processes, creating, reviewing, and maintaining regulatory documentation, as well as preparing for audits, evaluation procedures, and inquiries from regulatory authorities. Even after a product has been placed on the market, support is provided for market surveillance, vigilance, product changes, and the ongoing updating of documentation. The scope depends on the needs and ranges from one-time support to ongoing assistance in the agreed-upon areas of responsibility.
Result
Regulatory Support assists in agreed-upon areas of responsibility with the development and refinement of appropriate processes, as well as with the preparation and technical review of regulatory documentation, in particular:
- Establishment and further development of the quality management system in accordance with ISO 13485
- Structure, content, and consistency of technical documentation
- Documentation related to risk management, verification, validation, and software
- Technical support for clinical evaluation, performance evaluation, and clinical follow-up
- Procedural documentation for conformity assessment and certification
- Support with registration, UDI, and EUDAMED
- Market surveillance, vigilance, and technical classification of product changes
- Preparation for audits, evaluation procedures, and regulatory inquiries
- Documentation for national and international market access
Procedure
- Clarify requirements
Coordinate the product, life cycle phase, target market, procedures, timeline, and desired scope of support. - Assess the current status
Review existing processes, documents, and supporting evidence, and conduct a technical assessment to determine what needs to be adapted or supplemented. - Define the scope of work
Define the agreed-upon tasks and coordinate roles and responsibilities. - Implement and further development
Creation, revision, and coordination of processes, supporting documentation, and records, as well as a technical review—within the agreed-upon scope—to ensure completeness, consistency, and traceability. New requirements, product changes, and findings from market surveillance are taken into account within the agreed-upon scope of work..
As needed, coordination meetings or workshops support the implementation—for example, to address technical questions and interim status updates, as well as to coordinate the next steps.
Benefits
- Expert support for the practical implementation of regulatory requirements
- Support with documentation without the need to permanently build out additional capacity
- Reduced workload for development, quality, and regulatory teams
- Consistency across products, processes, evidence, and documentation
- Potential for fewer inquiries and less rework during audits and formal procedures
- Support for ongoing maintenance after the product is placed on the market
- Adaptation of existing documentation to new requirements, markets, and product changes
- Flexible scope ranging from ad hoc support to ongoing assistance in agreed-upon areas of responsibility
