Services

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