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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.



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