Remediations and support

Software Development

Experts in full Software Development Life Cycle and deliverables.

Engineering Consultants

FDA 483 Remediation

Years of experience resolving 483 Issues, and leading full remediation efforts.

our Services

Risk Management

PHA and SFMEA processes to meet ISO 14971

Software Verfication / Validation

• System Testing
• Unit Testing /Code Reviews
• Integration Testing Code & more

Contact US

​SEASONED PROS
OUR CONSULTANTS HAVE BEEN EVERYWHERE

With decades of experience in the Medical Device Industry and a broad range of expertise ranging from Software Development, Verification and Validation Activities, Test Engineering, Agile Development, Quality Systems, Remediation,

Risk Management, Project Management and more we are prepared to fulfill your needs.

Our consultants have successfully worked for the major players in the medical device industry. 

Let us put our experience to work for you.

Project Management / Scrum

Our resources are PMP and Scrum Certified!

"THEY SEARCH FOR TALENT, WE ARE THE TALENT"

FDA Regulatory Compliance

Quality / Regulatory & Cyber Security Services

Including meeting IEC 62304 for medical device software.