MEDTECH
Quality & Compliance Solutions
Regulatory Guidance. Proven Results.
For more than 30 years, the Founder of MEDTECH Quality & Compliance Solutions has helped medical device companies strengthen quality systems, prepare for audits, and navigate FDA, ISO 13485, and MDSAP compliance with confidence.
SERVICES
Our Solutions
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Development & Implementation, Certification
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Interim, Remote, Coverage & Management
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Internal Audit, Preparation, Training, Support
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Engineering Support
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Help, Submission, Compliance
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Services & Support
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Improvement, Investigations, RCA, Managementt 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
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Who We Are
The Founder, in combination with a team of seasoned established Consultants provide the professional help, solutions, and expertise to get the job done.
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
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• 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