×

HOW WE CAN HELP YOU

Quality and Regulatory Management System Consulting

header image

Don’t pay the high price of low quality and noncompliance. We are experts at helping companies solve quality and regulatory compliance problems. Let us help you!

  • Regulatory applications, mostly 510(K) pre-market notifications
  • Remediation, which we define as Quality Management System development and repair
  • Risk Management for both product safety and business

We are a trusted advisor who understands the headaches and hassles associated with everything from design and development through commercialization and post-market management.

We serve clients with the
following types of products:

Orthopedic <br>Medical Devices<
Orthopedic
Medical Devices
Cardiovascular <br>Medical Devices<
Cardiovascular
Medical Devices
General &<br>Plastic Surgery<
General &
Plastic Surgery
Electronic <br>Medical Equipment<
Electronic
Medical Equipment
Opthalmic <br>Products<
Opthalmic
Products
Physical <br>Therapy Devices<
Physical
Therapy Devices
Gastroenterology/Urology<
Gastroenterology/Urology
Combination <br>Products<
Combination
Products
Laboratories<
Laboratories
Contract <br>Manufacturers<
Contract
Manufacturers

We work closely with your business leaders and operate as a specialized extension of your cross functional business team to identify, remediate and transform costly business problems into highly-efficient and compliant operational and revenue generating machines.

We can equip you with the people, process and tools you need to eliminate the headaches, hassles and financial drain associated with non-compliance issues and their associated poorly performing business operations.

Read what some of our satisfied customers had to say after working with us.

To find out how we can help your business, contact us today for a free, confidential, no-obligation consultation