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.
Sterile Packaging
A leader in sterile-grade packaging for medical devices, Oliver-Tolas™ Healthcare Packaging's wide range of high performance packaging solutions meet virtually any requirement, regardless of device, packaging line specification or sterilization method.
Oliver-Tolas™ has ISO-certified manufacturing facilities located in Grand Rapids, MI; Feasterville, PA; Hamilton, OH and Venray, The Netherlands. Sales offices are located throughout the United States, Europe and in Suzhou, China.
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.
Product and Quality Management Certification
BSI Healthcare is a leading and well-respected Notified Body and Management Systems Registrar helping medical device manufacturers to place compliant devices on international markets. We offer robust regulatory and quality management reviews and product certification for medical devices. Our services include CE Marking, ISO 13485, CMDCAS, Japan PAL, FDA Third-Party Programs, Standards and Training.
Custom Thermoformed Plastic Packaging
Brookdale Plastics Inc. specializes in thermoforming plastic packaging solutions for the medical device industry, including finished device trays, as well as shipping and handling trays. The company also provides complete design solutions utilizing Pro/ENGINEER and SolidWorks software, and in-house rapid prototyping. Brookdale Plastics Inc. has certified Class 100,000 clean rooms and is ISO 9001:2000 certified.
R&D, Surgical Training & Biomechanics
Excelen is a consolidated orthopaedic resource. For future researchers, we provide educational opportunities, which may include patient care at Hennepin County Medical Center. For engineers, researchers, and physicians, we offer professional research facilities, expertise, and testing for the development of practical innovations in implants, instruments, and surgical procedures. Excelen helps successfully translate product concepts into reality, and increases orthopaedic knowledge through research and publishing.
