ADDRESSING DHF REMEDIATION CHALLENGES
1. DHF maintainance
Challenge: Maintaining a well-organized DHF is critical for ISO and FDA compliance across all phases of product development.
Solution: Decos reviews and updates your DHF to ensure it meets ISO 13485 and FDA standards, keeping your product in full regulatory compliance.
2. Safety and Effectiveness
Discrepancies in your DHF can risk non-compliance during audits, affecting product safety and performance.
Solution: Decos identifies and resolves DHF gaps to ensure your device meets safety and performance standards, reducing audit risks.
3. Legacy Documentation Gaps
Many medical devices have outdated or incomplete DHFs, complicating compliance with current regulatory standards.
Solution: Decos excels in reviewing and updating legacy DHFs, conducting comprehensive gap analyses, and revising technical documentation to align with the latest regulatory requirements.
4. Evolving Regulatory Standards
Keeping pace with constantly changing regulations can be overwhelming.
Solution: Our experts remain current with global regulatory requirements, such as FDA and ISO 13485 standards, helping clients update their DHFs and minimize non-compliance risks.
5. Verification and Validation (V&V) Compliance
Gaps in V&V testing can hinder compliance with modern standards.
Solution: We collaborate with your team to conduct essential V&V activities, including developing and updating protocols and supporting design verification testing.
6. Time and Resource Constraints
DHF remediation is resource-intensive, making it challenging to balance with ongoing product development.
Solution: Decos acts as an extension of your team, providing specialized expertise and streamlining the remediation process without disrupting your current projects.
7. Maintaining Market Access
Delays in DHF remediation can jeopardize market access due to potential non-compliance issues identified during audits.
Solution: We ensure swift and thorough remediation to meet regulatory deadlines, helping clients maintain uninterrupted market access and reducing the risk of recalls or penalties.
Audit Findings or Product File Issues?
Let our experts help you navigate and resolve compliance challenges.
Devesh Agarwal
Director Decos External Services
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