What keeps you up at night?
If your company manufactures medical devices, there’s a lot to worry about.
Product complaint backlog
Inadequate process validations
Design Control gaps
With a single focus on medical device manufacturers, GCI specializes in Quality Compliance Services including:
- Process Validation
- Method Validation
- Design Control
- Remediation of Quality Systems and records, including:
- CAPA files/records
- Complaint files/records and investigation
- Risk Management documentation
- Design History File remediation
- Technical File and Design Dossier updates
- Product and Process Controls
- Supplier Quality files
- And much more…
What makes GCI different than the rest?
With our proven “Balanced Team” approach, we provide the correct mix of talented biomedical engineers and technical managers to address your regulatory and quality compliance issues. A team of young, tech-savvy engineers, led by one or two technical managers, is a team of roll-up-our-sleeves do-ers. Why hire a team of chefs when what you really need is people to run the food out while it’s still hot? If you’re currently working with, or have worked with, outside experts, ask yourself if they provided a “Balanced Team.”
Our customers have raved about our approach and have thoroughly enjoyed working with our teams. See our customer testimonials.
Are you our next customer?
GCI is honored to have partnered with a large number of medical device manufacturers, including global, Fortune 100 customers, assisting them with some of the very same issues you may be facing today.
Have a look around our website. We believe you will find confidence in GCI’s ability to help you with your needs, and we think you’ll agree with our core values and business model.
Enjoy the relief of finally reaching your quality compliance objectives. Contact us today to speak with a member of our team.
We don’t believe in finding a temporary fix to an underlying issue. We will determine the issue and remediate it permanently to meet the guidelines and regulations of the FDA and EU. At GCI, we possess the talent, knowledge, and experience required to handle any regulatory compliance issues, validation, engineering services, cost-saving solutions, training, and record remediation. When you need us, we’re there.
Director of Operations, Abbott Vascular
Lorraine M. Hanley
Vice President – Global Regulatory Affairs, Navilyst Medical Inc.
Certification Officer, TUV Rheinland of North America, Inc.
“GCI possess the skills and knowledge required for quality and regulatory systems, while displaying the utmost professionalism. GCI’s disposition instills confidence, trust and security clients will be seeking.”
Director of Quality Assurance, Boston Scientific Corp.
“GCI provides great leadership and consistently meet the commitments they make. Their greatest strength is the understanding of industry requirements and applying them to everyday applications. I strongly recommend GCI for any opportunity within the Medical Device Industry.”
Daniel L. Liberacki
Program Management Office, Orthopedics Medical Device Manufacturer
Former FDA Supervisory Investigator
Former CFO, Biomet 3i
“Roberta Goode was introduced to our company at a critical time when we needed strategic quality system guidance and hands on support. Roberta and the Goode consulting team provided immediate assistance and played a key role in leading our company to a best practices state. The GCI team possess’ high levels of competency and experience in specific technical areas. ”