Ramona joined Experien Group in 2009 and possesses over 20 years of experience in the medical device industry. She is an expert in the development and implementation of Quality Management Systems that comply with FDA’s Quality System Regulation (QSR), ISO 13485:2003, ISO 14971:2007, the European Medical Device Directive, Health Canada’s Medical Devices Regulations (SOR/98-282 and CMDCAS scheme), and other relevant standards. Ramona has been extensively involved in quality assurance for sterile disposable medical products and is an expert in sterilization validation and aseptic processing. She is highly knowledgeable about product usability/human factors requirements, as well as the IEC 60601 electrical equipment series of standards.
At Experien Group, 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 QSR requirements. Her additional functions include:
- Quality Management System development and compliance to relevant standards
- Biocompatibility and medical device safety testing
- Product sterilization validation (e.g., EtO and radiation)
- Cleaning and steam sterilization validation for reusable products
- Manufacturing process validation (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 FDB Inspectors
- Internal audits, supplier audits, and management reviews for companies
- U.S. regulatory submission review and support (e.g., 510(k)s, IDEs and PMAs)
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 the writing of business plans and determining budget allocations for new technologies. Ramona has earned her ISO 13485:2003 Lead Auditor Certification, Aseptic Processing Certification, and RAB Lead Assessor Certification. She is also accredited by the RAB and IRCA for ISO 9000.
Ramona earned her BS in Business Management from the University of Phoenix in San Jose, California.