Quality & Regulatory Consulting

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Quality Assurance

Key Tech’s quality assurance team supports companies, from startups to global corporations, to ensure that products and processes comply with the latest quality standards and regulations. Key Tech has over twenty-five years of hands-on experience developing medical, IVD, pharmaceutical, and life science devices under FDA and ISO compliant quality management systems. Our quality assurance consulting services are offered as both standalone engagements and as part of our technical programs.

Regulatory Affairs

Key Tech’s regulatory expertise spans medical, IVD, and pharmaceutical device markets. Our team can help you identify the optimal regulatory path and ensure that your product meets the latest requirements. Our combination of regulatory expertise and in-house design and development capabilities allow us to both plan and execute in compliance with applicable regulations. Our team and vetted subject matter RA partners have you covered in all areas of regulatory compliance.

Quality Assurance and Regulatory Affairs Solutions

KeyTech QualityAssurance

21 CFR Part 820 and ISO 13485 compliance support
Review of existing product DHF & compliance gap assessment
Remediation plan and implementation to bring DHF into compliance
Compliant design control documentation (planning, design inputs, outputs, reviews, verification & validation)
Review of quality management systems and summary of identified issues
Preparing DHF documentation for FDA and notified body submissions

KeyTech RegulatoryAffairs

Strategizing regulatory path to market; 510(k), PMA, De Novo, and CE marking in compliance with MDR or IVDR.
Identification of applicable regulations and their impact on development scope
Gap assessment of product/program for compliance with applicable regulatory requirements
Applying FDA guidance in areas such as software development, usability engineering, and cybersecurity.
Identification of relevant FDA consensus standards and EU harmonized standards
Ensuring devices have suitable pedigree for clinical studies and V&V testing
Coordination of regulatory authority interaction (e.g., FDA Q-sub meetings)
Support preparing submissions to regulatory authorities