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.

Flexible Approach:

  • 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:
  1. Conduct a Gap Analysis
  2. Develop a Quality Plan
  3. Develop required Procedures and Supporting Documentation unique to your business needs
  4. Conduct a Pre-Certification Audit Assessment