This is the final appearance of a 510K that is produced by
Compliance Consultants!
The FDA is asking for both paper and electronic versions. In these four volumes, there are about 800 pages consisting of descriptions, claims, comparisons, specifications, instructions, tests, procedures, records, risk analysis, controls and ...
You must provide/create all engineering documentation (requirements, technical description, definitions, testing and qualifications) to support the production of documents. You must pay the User Filing Fee.
The FDA is asking for both paper and electronic versions. In these four volumes, there are about 800 pages consisting of descriptions, claims, comparisons, specifications, instructions, tests, procedures, records, risk analysis, controls and ...
You must provide/create all engineering documentation (requirements, technical description, definitions, testing and qualifications) to support the production of documents. You must pay the User Filing Fee.
