Med-Tech Consulting
Med-Tech Consulting provides technical consulting for Medical Device, Biomaterials, Pharmaceuticals, and Diagnostic companies, assisting with regulatory requirements documentation, quality systems, and validation testing. They support clients' Quality Management Systems from a regulatory perspective, offering services such as QMS system integration, process validation, IQ/OQ/PQ, test method validations, ISO 13485/14971 gap assessments, and FDA QMS and CFR Part 11 compliance.
Industries
Nr. of Employees
small (1-50)
Med-Tech Consulting
Lauderdale By The Sea, Florida, United States, North America
Services
Regulatory and quality systems consulting
Advisory services to align quality systems with regulatory requirements, perform gap assessments, and develop QMS documentation.
Validation and qualification services
Execution of process validation, IQ/OQ/PQ equipment qualification, software validation, and test method validation.
ISO and regulatory gap assessments
Assessments against ISO 13485 and ISO 14971 and alignment with FDA QMS and 21 CFR Part 11 requirements.
Process improvement and project management
Application of Six Sigma and project management to streamline processes and manage regulated product initiatives from inception to completion.
Regulatory and quality systems consulting
Advisory services to align quality systems with regulatory requirements, perform gap assessments, and develop QMS documentation.
Validation and qualification services
Execution of process validation, IQ/OQ/PQ equipment qualification, software validation, and test method validation.
ISO and regulatory gap assessments
Assessments against ISO 13485 and ISO 14971 and alignment with FDA QMS and 21 CFR Part 11 requirements.
Process improvement and project management
Application of Six Sigma and project management to streamline processes and manage regulated product initiatives from inception to completion.
Expertise Areas
- Quality management systems (medical device and life sciences)
- Process validation and equipment qualification
- Regulatory compliance (FDA QMS, 21 CFR Part 11, ISO 13485, ISO 14971)
- Software validation for regulated environments
Key Technologies
- Quality Management Systems (QMS)
- IQ/OQ/PQ equipment qualification
- Test method validation methodologies
- Software validation frameworks for regulated systems