Services
How can we achieve compliance?
R&D & Quality Assurance
-
Technical File
-
Design History File
-
Risk Management (ISO 14971)
-
Nonconformance Evaluations
-
Corrective and Preventive Actions (CAPA)
-
Supplier Quality
-
Usability (Human Factors)
-
Test Method Validation
-
Verification & Validation (Transit, Cleaning, Thermal Disinfection, Sterilization, Biocompatibility, Aging, Performance)
Quality Management Systems
-
Internal/External Audits
(ISO 13485:2016, 21 CFR 820,
EU MDR 2017/745) -
Establishing an eQMS
-
Management Review
-
Procedure Writing
-
Training
Regulatory & PMS
-
CE Mark submissions
-
FDA Q-submissions, 510(k)
-
Unique Device Identification
-
Clinical Evaluation Plan & Report
-
Regulatory Strategy
-
Complaint Handling
-
Post-Market Surveillance (PMS) Plan & Report
-
Post-Market Clinical Follow-up
-
Periodic Safety Update Report
About
Emily Skanron, Principal Consultant
Emily Skanron brings over a decade of global experience in the medical device industry, spanning the U.S., EU, and other international markets. She has applied her expertise in areas, such as risk management, in both large corporations and agile startup environments.
​
Her career began in engineering and R&D, evolving into leadership of quality and regulatory functions. This progression shaped her into a leader who deeply understands the impact of quality systems and regulatory requirements on product development. Emily modernized company procedures, including eQMS implementation. She directed products from concept through market launch, developing the verification and validation strategies that accelerated time to market.
​
As an ISO 13485:2016 Lead Auditor with formal training in 21 CFR 820 and EU MDR 2017/745, Emily has successfully navigated audits both as auditor and auditee with regulatory bodies and suppliers, ensuring compliance with the latest standards and regulations.
​
Emily is passionate about empowering teams to succeed collaboratively and advancing innovative medical devices that improve patients’ lives.
