Quality Management
Quality Management Systems
Quality System Audits
(Gap, Internal, Supplier)
Quality System Remediation
Software Validation
Major Nonconformance,
FDA 483, Warning Letter
Vendor Management
Training and Education
Post Market Surveillance
Due Diligence
eQMS
Interim Quality Professionals
Regulatory
Global Regulatory Strategy
Due Diligence
Training and Education
Global Regulatory Submission
US Regulatory Submissions
Pre-sub, 513(g), 510(k), De Novo, PMA
Global Regulatory Registration
eTD
Interim Regulatory Professionals
EU MDR/IVDR Technical Documentation
UKCA Technical Documentation
Clinical
Clinical Evaluation Planning
Medical Writing
Training and Education
Gap Assessments
Clinical Performance Evaluation Report
Scientific Validity and Analytical
Performance Planning
Clinical Evaluation Reporting
Post Market Clinical Follow UP
Due Diligence
Performance Evaluation Planning
Literature Searches
Post Market Performance Follow Up
Engineering
Risk Management ISO 14971
Medical Device Software Compliance
IEC 62304
RoHS/REACH/WEEE
Process Validation
Design History File Development and Remediation
Due Diligence
Usability IEC 62366
Cybersecurity
Safety IEC 60601
Test Method Validation
Packaging and Shelf Life
Training
We offer on and offsite training for all aspects of Medical Device Quality and Regulatory processes
EU MDR / IVDR
Risk Management
ISO 13485/QSR
MDSAP
Clinical Evaluation
Post Market Surveillance