MEDTECH
Quality & Compliance Solutions (QCS), LLC
Quality & Compliance Solutions for Effective Product Development and Success
Accelerating your medical device from concept to commercialization. We partner with start-ups through every phase of product realization to build compliant, market-ready technology without slowing down innovation. Then we support product release and continued Quality & Compliance as you grow. We specialize in working with Start-Ups and Mid-Size companies.
SERVICES
Our Solutions-we partner with you to assess, evaluate, strategize, and execute
Supporting MedTech & HealthTech Products
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Development & Implementation, Certification
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MedTech and HealthTech product support services and resources
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Interim, Remote, Coverage & Management
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Internal Audit, Preparation, Training, Support
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Engineering Support - Hazard Analysis, FMEAs, V&V Protocols and Reports, Data Analysis
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Help, Submission, Compliance
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Services & Support
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Improvement, Investigations, RCA, Management Support
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Interim Coverage and Support
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Issues Resolution, Process Improvement
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Supplier evaluation and qualification support
Supplier Audits and Capability Analysis
Quality Issue Resolution
Process Validation Services
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Regulation & Standard Guidance, Application
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Planning, Evaluation, Assessment, Residual Analysis, Reports
General Consultation
Quality, Product Development, Regulatory Compliance
Who We Are
The Founder, in combination with a proven extended team of seasoned established Consultants and Contractors provide the professional help, expertise, and SOLUTIONS to get the job done. Click here to review our expert resources.
Meet the Founder, Barry Camrell
ABOUT US
Barry Camrell has successfully developed, established, and applied Quality Management Systems (QMS) to numerous medical device companies through his career, taking over 50 products from concept to release in a variety of roles. He’s conducted Internal Audits for decades, prepared and facilitated both ISO13485, MDSAP, and Intl Reg Audits with great success, passing results, and leading to full re-certification of the related QMS.
The Quality Systems he has established have passed both FDA and Certification Organization Audits.
The unique combination of working for years as a Medical Device Engineer himself, combined with the exposure, training, certification, and experience of Regulatory Affairs is what makes a real difference in the success.
Why MEDTECH QCS
A Trusted Partner in Medical Device Quality
30+
Years of Experience in Medical Devices
50+
Products Successfully Brought to Market
25
Years of Successful Audits Supported
Global
Product Launch Experience
Submit an Inquiry
• 30+ years of medical device engineering, quality assurance, and regulatory compliance experience
• Successfully brought 50+ medical devices from concept to market release
• Extensive expertise in FDA, ISO 13485, MDSAP, and international regulatory compliance
• Proven track record establishing Quality Management Systems that pass FDA and Certification Body audits
• Specialized experience in Quality Assurance, Quality Control, CAPA, Risk Management, and Design Controls
• Trusted partner for audit readiness, quality system improvement, and regulatory compliance support