Ramona joined Experien Group (now Veranex) in 2009 and possesses over 30 years of experience in the medical device industry. She is an expert in the development, implementation, and successful management of quality management systems for Class I, Class II, and Class III medical devices that comply with the FDA’s Quality System Regulation 21 CFR Part 820, EN ISO 13485, EN ISO 14971, the European Medical Device Directive (MDD), and transition to the European Medical Device Regulation (MDR), Canada’s Medical Devices Regulations SOR/98-282, including specific requirements of medical device regulatory authorities participating in the Medical Device Single Audit Program (MDSAP), and other relevant standards. Ramona has been extensively involved in quality assurance for collagen-based technologies, capital equipment, software driven medical devices, combination products, and sterile devices. She is an expert in sterilization validation and aseptic processing and is highly knowledgeable about product usability/human factors requirements, as well as the IEC 60601 electrical equipment series of standards.
At Veranex, Ramona works closely with companies’ technical teams. She supports design control and risk management activities for clients. She regularly performs gap analyses, internal audits, and other quality management system assessments. Ramona performs compliance reviews for a variety of product lines. She leads clean room validation projects and oversees technology transfers in compliance with applicable ISO and FDA’s Quality System Regulation requirements. Her additional functions include:
- Quality management system strategic planning and partner alliances
- Quality management system development and compliance to relevant standards
- Biocompatibility and medical device safety testing (including interfacing with contract manufacturers and testing laboratories)
- Product sterilization validation (e.g., EtO and radiation)
- Cleaning and steam sterilization validation for reusable products
- Manufacturing process validation risk-based approach (e.g., installation, operation, and process qualifications)
- Product manufacturing and distribution considerations (e.g., supplier quality)
- Interface with FDA inspectors, notified body auditors, and state of California Food and Drug Branch (FDB) inspectors
- Technical review for U.S. and EU regulatory submissions, including IDEs, 510(k)s, PMAs, technical files, and design dossiers
- Quality requirements and regulatory submissions for CE marking
- Internal audits, supplier audits, and management reviews for companies
Past companies and experience
Ramona has been a professional in the life sciences industry and manufacturing operations since 1985. She has held management roles at Collagen Aesthetics, Inamed Corporation, Allergan, and Aesthetic Sciences. She has overseen quality management systems and project management activities for global product lines, including supplier agreements and the establishment of international product distribution chains. Ramona has directed long-range strategic planning at several companies, including writing business plans and determining budget allocations for new technologies. Ramona has earned her ISO 13485 Lead Auditor Certification, Aseptic Processing Certification, and RAB Lead Assessor Certification, and is accredited by the RAB and IRCA for ISO 9000.
Ramona earned her B.S. in business management from the University of Phoenix in San Jose, California.