Design Control

Medical Device Design Control Expertise

MedDev Consulting LLC can help you create design control procedures and/or design control documents as required by FDA under 21CFR820 and ISO 13485, as part of your quality management system.  With over 25 years of industry experience with product development and quality systems, we can create the documents for you, work with someone on your staff to collaborate, and/or teach your staff the details and intentions of these documents as they apply to your product(s).