Quality & Regulatory

Medical Device Regulatory and Quality Consulting

Medical Device Quality Consulting

Quality assurance is critically importance in the medical device sector. You need to be certain that what your company delivers to the public has been thoroughly vetted to the highest regulatory standards. As a leading quality management consultancy, GForce Life Sciences is dedicated to providing solutions laser-focused on your highly demanding industry. Our expertise in medical device quality consulting will assist you in each phase of your project’s development.

GForce is one of the top QA consulting companies in large part because of the complete range of services we offer. Our medical device QA capabilities include validation, mock FDA audits and process design, as well as acting as your FDA 510(k) consultant.  

Medical Device Regulatory Consulting

Could your company benefit from an outside FDA medical device consultant? In addition to our quality assurance services, GForce Life Sciences offers a full range of regulatory support, from initial strategy and submissions to meeting and working with the FDA. Our expert insight helps extend the reach of your regulatory team or can handle everything as your regulatory department. Our qualified professionals provide consulting advice from the early phases of medical device development through marketing applications and post-market activities.

Our regulatory compliance services are designed to meet ISO requirements. This means we help you develop quality management systems that demonstrate the ability to meet all statutory and regulatory requirements while enhancing customer satisfaction through their effective application.

Medical Device Quality Assurance Services

  • Remediation Services
  • Manufacturing Oversight (GMP)
  • Process Deviation & CAPA Management
  • Process Design, Harmonization & Validation
  • Compliance
  • Verification & Validation
  • Unique Device Identification (UDI)
  • Design History File (DHF)
  • Device Master File (DMF) & Device Master Record (DMR)
  • Post-Market (Complaints, Adverse Events, Recalls)
  • QA SOP Development
  • Site and Vendor Qualification & Auditing (GMP Accreditation)
  • Mock FDA, Supplier/Distributor, SOP Audits
  • Inspection Readiness

Medical Device Regulatory Consulting Services

  • Manage regulatory affairs
  • Prepare or review dossier/submissions and file
  • Direct Site & Vendor Qualification and Auditing (GMP Accreditation)
  • Ensure ISO 9001, 13485, 14971 and many more Code of Federal Regulations (CFR) Part 11, 211, 820 and more
  • Prepare submissions to other worldwide agencies in Europe, Middle East, South America, Australia and Asia
  • Develop regulatory strategy for the product’s life cycle
  • Provide scientific and medical writing services
  • Manage regulatory electronic submission publishing services (eCTD)
  • Support post-market activities (complaints, adverse effects, recalls)
  • Oversee EU MDR/IVDR (Medical Device Regulation/In Vitro Device Regulation)

“I was extremely impressed with the high level of professionalism that the team brought to our site. They integrated quickly and became a part of our company mission. What impressed me most was seeing how the GForce team responded to the high expectations set during remediation efforts and how they exceeded them.”

— GForce Client

Learn how GForce Life Sciences can help accelerate your growth.