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.”