About MDRG
The Medical Device Resource Group is a coalition of Twin Cities companies that together offer the broad expertise you need to get new devices to market – and support them once they're launched.
Look to Members of the Medical Device Resource Group for
Marketing, Strategy and Design
We're specialists in fast, efficient, effective medtech and life science product launches and revitalizations. More than two decades of our medtech marketing experiences have been captured in our proprietary process. Whether finalizing your nearly-developed product's definition, rejuvenating your legacy product's weakened market performance, or solving a marketing challenge that's somewhere in-between, we cost-effectively produce results.
Analytical Chemistry
Standard and unique analytical chemistry and physical testing ranging from routine quality control analyses to customized developmental and FDA validation procedures.
Package and Product Testing
Testing for compliance with national and international regulations related to:
- Package integrity validation – accelerated aging and shipping/distribution simulation testing;
- Product/material services – ISO product performance and safety, mechanical tensile strength, materials and assemblies strength, electrical properties and performance, shock and vibration testing.
Toxicology
FDA/ISO/EN and Japanese compliance testing service, including in vivo and in vitro toxicology, genetic toxicology and microbiology.
Assembly and Packaging
Assembly, packaging and contract sterilization (EO, gamma & E-beam); project management; innovative process development solutions; material sourcing; purchasing; and package design.
Clinical Trial Software
Validated software solutions for pre-clinical, Phase I-IV clinical and post-market studies. Originally designed for medical device studies, Clindex is now instrumental in bringing a wide range of products to market, including diagnostic, analytic, pharmaceutical and medical device products. Fortress Medical Systems' Clindex Clinical Trial software has been used in hundreds of trials in the US and abroad.
Packaging Design and Materials
Oliver-Tolas Healthcare Packaging is the leader in sterile-grade packaging materials for medical devices. Oliver-Tolas' wide range of superior performance medical device packaging solutions meets virtually any requirement, regardless of device, packaging line specification, sterilization method or cost.
Oliver-Tolas serves customers from an ISO 9001:2000 registered facility in Grand Rapids, Michigan, USA and an ISO 9001:2000 registered, class 8 clean room facility in Venray, the Netherlands.
Labeling, Literature and Packaging
For more than 25 years, we've been partnering with medical device manufacturers to create the right labels for the toughest applications. We understand the unique demands of medical device packaging.
Regulatory, Clinical and Quality
Providing expert consulting to medical device, IVD, and combination product industries. Consulting services include: regulatory affairs, clinical trial design and management, database development, quality systems and compliance, biostatistics, reimbursement, health economics, preclinical, and venture capital due diligence.
Management Systems
BSI Management Systems is the world's leading management systems registrar and CE marking Notified Body, helping medical device manufacturers understand what to do to place compliant devices on international and domestic markets. BSI helps companies to improve quality and manage risk through CE marking, ISO 13485, CMDCAS, Medical Device Testing, US FDA 510(k) Review, standards, publications, and training courses.
IP, Corporate and FDA Law
Fredrikson & Byron's attorneys advise medical device companies on capital formation, general corporate matters, FDA matters, licensing, patents, trademarks and service marks, securities compliance, employment, real estate, and more. Our clients look to us for advice when obtaining product approvals and conducting clinical studies, as well as when the need arises to undertake corrective actions, such as product recalls or withdrawals.
