– cGMP in Medical Devices
– Meet the 21 CFR 820 requirements for Quality System Regulation on the methods used in, and the
facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and
servicing of all finished devices intended for human use.
– Ensures that finished devices will be safe and effective and otherwise in compliance with the Federal
Food, Drug, and Cosmetic Act.
– Send the approved company logo and your facility address to be incorporated on the documents, if
applicable, to email@example.com.
– Google Meet – Screen Share for discussion. To be scheduled by our Health Care Team, if applicable.
– Program(s), Policy (or Policies), Procedure(s), and Form(s) purchased require customization, review, and
approval for their intended use. Review and approval are not included in this service.
– Should you need customization assistance, please schedule a complimentary discussion via Google
meet screen share with our Health Care Team by emailing firstname.lastname@example.org.
– Recommendation and guidance given or implied are based on best practices and the adherence to a
regulatory or certification body requirements and may or may not conform to the requirements or the
intended use or application.
– Program(s), Policy (or Policies), Procedure(s), and Form(s) created requires review and approval by your
company’s authorized personnel and qualified personnel.
– Program and Applicable Form(s) in word or excel format.
– Approved Supplier program
– Foreign Supplier Approval program
– Supplier Audit program
– Receiving Protocol Requirement for Specimen Collection Kits
– Non-conforming Materials and Product program
– Product sampling, inspection, and analysis program
– Product Identification program
– Product Trace program
– Storage and handling of goods program
– Stock rotation procedures
– Loading, transport, and unloading practices program
– Specifications (Raw Material, Packaging, Finished Product, and Services)
– Product release program
– Finished product labeling program
– Finish product specification program
– Contract service provider program
– Contract Manufacturers program
– Product Release program
– Records program
– Receiving program
– 63 Business Days upon receipt of the completed information required for inputs