Medical Device Quality & Regulatory Consulting

Experienced FDA Consultants for Medical Device Compliance

Quality assurance and regulatory compliance are some of the most important factors to consider when launching successful medical devices. You need to be certain that the devices your company delivers to the public have been thoroughly vetted and properly manufactured, or else you may fall victim to costly and time-consuming penalties. There’s also the matter of ensuring that your products meet all regulations in the markets where they will be sold. Considering how often the regulatory landscape changes, your company needs medical device quality consulting that makes sure all the bases are covered.

Luckily, GForce’s team of medical device compliance consultants are ready to help you manage product life cycles and classification standards and launch new devices without delays or regulatory mishaps. When we serve as your medical device regulatory consultants, you leverage our extensive expertise to successfully guide your new products through the complex and challenging process of achieving compliance. Even if you’re innovating an old design, our experts are dedicated to delivering consistent value to your business. We put our experience to work for you, however you need it. We’ll even act as your FDA 510(k) consultants to ensure successful Premarket Notification.

Unmatched Regulatory Guidance & Support

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 outsourced regulatory department. Our qualified professionals provide consulting advice from the early phases of medical device R&D through marketing applications and post-market activities.

Our medical device regulatory consulting 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. With the ongoing advice and support from our FDA consultants for medical device development, you can rest assured there will be as little friction as possible during your regulatory process.

QA Solutions

  • 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 Affairs Consulting

  • 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.

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