If You Ask Questions Like These, MedTech Dynamics Can Help
Product development
How do I fix my design history file?
How do I get EMC and electrical safety testing done?
How do I design for manufacturing and service?
How do I get my product sterilized?
What is Risk Management?
Quality
regulatory
I don’t have time to implement an ISO 13485 Quality Management System. How do I get it done?
How is a regulatory strategy developed?
I’ve never dealt with the FDA, what do I do?
I’m getting a regulatory audit, what do I need to do?
How do I get CE Mark?
Manufacturing
supply chain
How do I get my product manufactured?
How do I find a Contract Manufacturer at a reasonable cost?
How do I get reliable suppliers?
I need to get my manufacturing process validated for GMP. How do I do that?
IT/project management
My ERP/eQMS is not supporting the company’s operations. What can I do?
My product project is behind schedule. How do I get it fixed?
I don’t have time to coordinate the team. I need help?
What tools can help me run my project?
Get to Know MedTech Dynamics
Led by Joe Argyros – Making Your success The Only Focus
With over 30 years of experience in early-stage medical device companies, Joe Argyros is a leading expert in providing efficient solutions for medical device startups. Joe has led many product introductions with leadership in all aspects of product development, regulatory clearance, manufacturing, quality, IT, and servicing. He has led efforts for multiple 510(k)’s, CE Marks, Emergency Use Authorizations, and a PMA Clinical Trial. Joe has implemented processes and IT systems that have successfully passed multiple ISO 13485, FDA’s 21 CFR Part 820 and sterilization audits. His experience will identify areas that can help to commercialize your products while maintaining compliance and efficiencies.
Having an initial exploratory conversation is important and welcomed. Please send an email to [email protected] to start the process.
Tailored Solutions That Meet Your Needs
MedTech Dynamics understands that there are no “One Size Fits All” solutions. Listening to your needs and learning about your company’s journey are the first steps in the process. Solutions that are developed take into account how the outcomes will affect the entire company. Implementing in a “Silo” environment is not done.
Examples Of Some Available Solutions:
Investigate and Guidance Only
Implement a Quality Management System
Engage in Project Work to Complete Tasks
Interact with Regulatory Bodies, Suppliers & Manufacturers
Manage Projects
Assist in Internal Processes and Information Technology
Any Other Support Requested
Contact
Certified U.S. Small Business Administration
Veteran Owned Business