Quality Management
Quality Management Systems
ISO 13485 / MDSAP
Development / Remediation
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
FDA, EU MDR / IVDR, UKCA, Global Pathways, Technical Documentation
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
Risk, Design & Software
Risk Management ISO 14971
Design Controls / DHF
IEC 62304
RoHS/REACH/WEEE
Process & Software Validation
Medical Device and Software Compliance
SaMD Validation
Design History File Development and Remediation
Due Diligence
Engineering
Usability IEC 62366
Cybersecurity
Safety IEC 60601
Test Method Validation
Packaging and Shelf Life
Post-Market Crisis Support
Vigilance / Adverse Events
FSCA/ Recalls
Audit Front-room / Back-room support
Findings
Responses
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
Training
We offer on and offsite training for all aspects of Medical Device Quality and Regulatory processes
Custom and Standard Courses
EU MDR / IVDR
Risk Management
ISO 13485/QSR
MDSAP
Clinical Evaluation
Post Market Surveillance