We specialize in strategic guidance and tactical program implementation for medical device companies facing quality and regulatory challenges.
Regulatory submissions and strategy (PMA, 510(k), BLA, IDE, etc.)
EU MDR
IVDR
Medical Writing (CER & Safety Reporting)
Field Actions/Recalls
International Submissions
Regulatory Strategy
QMS
Quality Assurance
Risk Management
CAPA / Non-conformance
Remediation
Post Market – Surveillance & Complaint Handling Services
Change Control
Cleaning
Equipment and Process
Test Method
Software Validation
Sterilization
Product Development Design Quality Engineers
Mechanical and Electrical Engineers
Biocompatibility
Software Quality
Technical Transfer
Technical Transfer
Process and Product Development
Technical Writing
MFG Engineering
Automation
Built on our experience helping companies navigate complex cases with the FDA, we have developed a philosophy and a set of core service offerings that focuses on device risk management. Our process addresses requirements of the enforcement process and quickly reduces the risk to consumers. Consistently and Effectively.
With our staffing DNA, we know how to find the right consultants and talent for the right roles, whether that is to develop strategies, build and manage programs, or execute key projects. Some recent roles we have filled with medical device companies include:
22 Roulston Road
Windham NH 03087
3200 N. Hayden Rd, Suite 205
Scottsdale AZ 85251