Medical Device Experience:
- Michaela Shaw, the principal consultant at Shaw Quality Solutions has over 15 years experience in the medical device Quality Assurance and Regulatory field.
- She has participated in dozens of audits so has a deep understanding of auditor expectations.
- Works with a diverse group of companies: start-ups, high growth companies and established multi-facility medical device organizations.
- Certified Biomedical Auditor trained in ISO 13485, FDA QSR, and MDD requirements.
Proven QMS Knowledge:
- Uses proven Quality Management System templates that have successfully passed dozens of audits
- Customizes the QMS to fit company’s needs (not a boiler plate).
- Continues to develop and support the in-house QA team throughout the implementation of the QMS.
- Ongoing management of the QMS as the lead of your QA team facilitating the QA functions for design, production and management processes.
- As the sole consultant, you receive personal, friendly, on-site attention.
- Flexible and Adaptable project plans that are customized for your company’s development stage, market plan, size and culture.
- Multi-Stage approach to QMS Implementation projects:
- Conduct a Gap Analysis
- Develop a Quality Plan
- Develop required Procedures and Supporting Documentation unique to your business needs
- Conduct a Pre-Certification Audit Assessment