QMS.Coach LLC

QMS.Coach LLC provides expert quality management and regulatory compliance consultancy with a focus on the medical device industry. Founded on a deep technical foundation in bioengineering, the firm moves beyond simple documentation to ensure that quality systems work in harmony with complex product designs. By leveraging hands-on experience from industry leaders such as Medtronic and Edwards Lifesciences, QMS.Coach identifies critical quality gaps and operational risks that generalist compliance consultants often overlook.

The practice specializes in audit readiness and supplier quality management, particularly for organizations navigating the transition to EU MDR and the new FDA QMSR requirements. With a track record of reducing audit findings by up to 40 percent through structured readiness programs, the firm provides ISO 13485 Lead Auditor expertise to ensure businesses are prepared for FDA inspections and Notified Body audits. This technical proficiency is backed by a suite of professional credentials and a focus on accountability and efficient delivery.

Core Specializations:

• ISO 13485 Compliance and Lead Auditing

• FDA QMSR and EU MDR Transition Strategy

• Enterprise Audit Readiness (For-Cause and Routine Inspections)

• Supplier Quality Management and Risk Assessments

• PLM Documentation and Qualification Planning

Professional Credentials:

• Certified Medical Device Auditor (CMDA) and Certified Quality Auditor (CQA)

• Certified Supplier Quality Professional (CSQP)

• Project Management Professional (PMP) Certification

• Advanced Training in AI for Healthcare from MIT Sloan

• Academic backgrounds in Bioengineering and Technology Management