Team
Mercedes Massana
Consultant
With over 35 years of management and technical expertise in the medical device, pharmaceutical and biotechnology industries, Mercedes Massana has a unique skill set that combines expertise in quality management in regulated industries and product development. She has provided a broad range of services to clients ranging from start-ups to Fortune 500 companies, helping customers reduce development time while releasing quality products that meet or exceed expectations. Mercedes is a skilled group facilitator, auditor and trainer which makes her an ideal change agent. Mercedes has also served as an expert witness in the area of Software Development and Risk Management.
Academic & Professional Qualifications:
- B.S. Electrical Engineering, University of Miami
- INCOSE Expert Systems Engineering Professional (ESEP)
- ASQ Certified Quality Manager (CQMa)
- ASQ Certified Biomedical Auditor (CBA)
- ASQ Certified Quality Auditor (CQA)
- ASQ Certified Software Quality Engineer (CSQE)
Training, Quality Systems, & Specialties:
- Medical Device Regulations (MDR)
- In-vitro Diagnostic Regulations (IVDR)
- 21 CFR, Subchapter H (Medical Devices)
- ISO 13485 – Medical devices – Quality management systems
- IEC 62304 – Medical device software – Software life cycle processes
- IEC 62366 – Medical devices – Application of usability engineering to medical devices
- ISO 14971 – Medical devices – Application of risk management to medical devices
- Requirements Management
- Design Controls
- Safety Assurance Cases
- DHF Remediation
- Process Improvement
- Product Development Tools: DOORs / JIRA / Lean Design
- Fully bilingual, capable of facilitating workshops and training in Spanish
