Medical Devices

21 CFR Part 820 the Quality System Requirements, or GMPs, includes requirements related to the methods used in, and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.

EAS consultants ensure compliance with the specific requirements of QSR – as well as ISO 13485 QSR and FDA GMP harmonization pertaining to your particular device. We assist with the development and review of quality system protocols and policies, revise Standard Operating Procedures (SOP) as needed, and ensure complete and accurate compliance with Design History and Device Master Files requirements.

FDA inspects manufacturing facilities to assure compliance with the QS requirements. EAS provides support for the preparation of such inspections as well as support during the inspection to ensure smooth communication between the manufacturer and FDA inspector.

FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace. EAS offers mock-FDA inspections as well as FDA inspection support for foreign facilities to determine deficiencies and assist with corrective actions. Additionally, we assist with remediation activities in the event deficiencies are found. Proactive assessment is always better. Contact EAS for more details on our inspection services.

Each party engaged in the manufacture of a medical device is responsible for ensuring compliance with cGMPs for the manufacturing activities it performs including oversight and controls to ensure quality but ultimately, the brand owner contract manufacturer is responsible for ensuring that the product was produced using GMPs regardless of who performed manufacturing, packaging, labeling, holding or distribution. EAS assists with the preparation of Quality Agreements specific to your organization’s contractual relationships. Establishing a comprehensive Quality Agreement between parties will ensure that all quality requirements dictated in 21 CFR 820 or ISO 13485 have been assigned and will be performed by the appropriate responsible party.