Weir Consulting Group, LLC

Supporting the Innovation and Regulatory Compliance Needs for the

Medical Device, Pharmaceutical, API, and Biopharma Industries, Including:

Project Management

FDA Listing/Registration, PMA, 510(k), Audit Responses

ISO 13485 Certification

Process Improvement and Quality Remediation Initiatives

Design Quality Engineering

Computer System Validation (CSV), Software Validation

IT Infrastructure Qualifications

Process, Equipment, Facility/Utility, and Cleaning Validation

Test Method Validation

Laboratory Instrument Implementation and Qualification

Laboratory Information Systems (LIMS)