USA manufacturers

Every manufacturer of a medical device including Dental Laboratories must establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured (this is a FDA mandatory requirement)

The mandatory requirement is applicable to all organizations involved in the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use

If a manufacturer engages in only some operations subject to the requirements in 21 CFR 820, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged

Foreign manufacturers

Manufacturers of medical devices intending to market the device within the USA must be able to demonstrate compliance to these requirements

Lawrence-Hall Consultants, working closely with you, develop and implement your quality system and technical files. Our highly experienced and qualified consultants take the burden and stress from you and ensure your systems and documentation will meet the regulatory requirements.
Should you wish, your consultant will be present during the Notified Body assessment
Our consultants begin the certification process by conducting a Gap Analysis of your systems and documentation. The analysis report identifies the areas that are not in compliance with the 21 CFR 820 requirements and includes an action plan and timescale for full system implementation