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Medical Devices

Auk has years of experience assisting firms comply with the FDA requirements on medical devices.  Our capabilities include:

  • FDA Compliance | Master Planning and Strategy

  • Preparation for Inspections

  • Pre-approval and Mock FDA Inspections

  • Vendor / Supplier Audits

  • Gap Analysis

  • Formal Risk Assessment

  • Support with 483′s / Warning Letters / Consent Decrees

  • Assistance and Review of Regulatory Filings (IND’s/PMA’s/NDA’s/ANDA’s/BLA’s/510(k)’s/etc.)

  • Quality Systems Guidance and Development

  • Corporate SOP Guidance and Development

  • Mock Product Recalls

  • Assistance with Product Recalls

  • Process and Utility Design Review and Assessment

  • Facility Layout Review and Assessment

  • Dietary Supplements and Nutraceuticals

  • Assistance with Imports

  • 21 CFR Part 11 Compliance Strategies

  • Validation Master Plans

  • Equipment and Instrumentation Qualification

  • Utilities Qualification

  • Process Validation

  • Cleaning Validation

  • Analytical Methods Validation

  • IT Qualification and Computer Validation

  • Training and Development of Training Programs

Food Safety / FSMA

The FDA has recently rolled out the Food Safety Modernization Act, which significantly increases the requirements on food manufacturers.

Auk Technical Services has years of expertise in food safety and in risk management (a new requirement of FSMA), and training in the FSMA requirements.  Let us help you succeed in this new environment.

FDA 510(k)


ATS Delivers Your Road Map to 510(K) success by:

  • Building the 510(k) submission file (prepare preliminary reports on the feasibly of the concept, help select the predicate device, advise on FDA guidance available, advise on design control hurdles)

  • Creating the FDA expected Quality system (create the Quality Manual, SOPs and all Quality Forms)

  • Performing Mock FDA inspections by ex FDA Investigators (I cleared the 510(k), how do I survive the accompanying FDA inspection?)

FDA and ISO Mock Inspections and Mock 483 Issuance Services


Mock FDA or RAB ISO investigators will:

  • Issues mock 483’s

  • Issues mock ISO deficiency reports

  • We also critique the client behavior during the mock exercise

  • We issue a mock FDA Establishment Inspection report(EIR)

Medical Software and Firmware Development


Our FDA Consultants Assist you with:

  • Understanding FDA software expectations

  • Auditing and assessing FDA fitness of the Defect Management System

  • Getting the client process upgraded if necessary to FDA or ISO expectations for Risk Management

  • Designing and developing software/firmware

  • Assess readiness of the data regarding Verification and Validation of software/firmware

  • Creating an IEC 62304 compliant software development process

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