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Design Control
Design control is a key requirement which under-pins the ability for a drug delivery system to achieve international regulatory approval. Whether it be ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes or CFR Title 21 § 820 QUALITY SYSTEM REGULATION Subpart C – (CFR Title 21 § 820.30) Design Controls, PharmaDelivery Solutions Ltd can help. PharmaDelivery Solutions has been involved in a number of device programmes offering input, advice or providing documentation in such areas as;
- GAP analysis/ Audit on Existing design control systesms.
- Review/ Audit of design History Files (DHFs).
- Design and construction of DHFs.
- Templates for design review activities.
- Review/ Edit, Generation of User Requiremenst Specifications.
- Design of Design verification strategies.
- Design verification Protocols.
- GAP analysis/ review of Device Master Records.
- Negotiations on product and manufacturing specifications.
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.3
Copyright © 2004 PharmaDelivery Solutions Ltd All rights reserved.
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