Rapid Innovative Solutions
Med-Tech Consulting provides technical consulting for Medical Device, Biomaterials, Pharmaceuticals, and Diagnostic companies providing assistance with regulatory requirements documentation, quality systems and validation testing.
Supporting your Quality Management System from a Regulatory Perspective.
• QMS SYSTEM INTEGRATION
• PROCESS VALIDATION
•IQ/OQ/PQ, SW VALIDATIONS
•TEST METHOD VALIDATIONS
• ISO 13485/14971 GAP ASSESSMENTS
• FDA QMS and CFR PART 11
Our Customers
Introduce your team
Meet our Awesome Team of Consultants.
Team member
Quality / Validation Principal
Innovative MBA leader with expert knowledge of Research and Development, quality management, product development, and Six Sigma techniques in streamlining processes, identifying deficiencies, and producing solutions. Capable of driving initiatives from inception to completion with accountability for management of projects, people, and timelines. Creative troubleshooter with ability to multi-task and work well in demanding and fast-paced environments. Demonstrated expertise in interpreting regulations and compliance to develop and implement compliant products and processes. Solid communication and interpersonal skills; able to interact and collaborate with individuals at all organizational levels.
Maria Fernandez
Principal Regulatory Consultant
Experienced in Quality Management, Validation and Regulatory environments.