Common Sense Meets Compliance
WHAT WE DO
QUALITY ASSURANCE
Building and tailoring quality management systems to the needs of organizations.
Your systems should support safe and effective products, not get in the way of development.
Expertise includes: ISO 13485, MDSAP, IEC 60601-1, IEC 62304, IEC 62366, MDR and other global requirements.
REGULATORY STRATEGY
There is no regulatory strategy separated from technology novelty and marketing goals.
We help you with the Regulatory piece of your Product-Market-Regulatory Fit equation.
SOFTWARE SYSTEMS
Software systems (eQMS, Document Management Software, Product Lifecycle Management, etc.) should make compliance easy, not get in the way of it.
If you are spending multiple hours working against your software system, let's talk.
LOOKING FOR OTHER CAPABILITIES?
We have a network of like-minded consultants who would be happy to help!
WHY CHOOSE US?
We consult because we love working with medical device companies. We have experience in a variety of domains, satisfying the needs of micro, small, medium, and large enterprises.
We will never put our revenue above helping a device company come to market.
Product Launch and Regulatory Strategy
Product categories taken from concept through regulatory to international launch include:
- Electromechanical systems
- Optical systems
- Mechanical systems
- In-Vitro Diagnostics
- Software as a Medical Device
Quality System Implementation
Quality Management Systems implemented from ideation to global commercialization.
Focus on people: Perfectly implemented procedures ultimately mean nothing without the buy-in of the team.
Software Systems Implementation
Whether implementing new software systems or taking advantage of the capabilities of existing under-utilized systems, we can help.
TEAM
ARIE HENKIN
Founder / Principal Consultant
CONSULTANT NETWORK
- Usability / human factors
- Design controls
- Systems engineering
- Product management
- Clinicians