We have decades of experience tackling the most demanding challenges, from engineering all the way through the nuances of regulatory and supply chain operations.
Excellence
Bringing your life-changing devices to market.
Medical Device companies turn to us for advanced strategy and hands-on knowledge. Our network of regulatory experts will complement your internal team to overcome complex challenges and resolve quality and compliance issues.
what our customers say
“Knowing how to match consultants with the industry knowledge who can jump right in, hit the ground running, and make it work for clients is why The Evanston Group is a top-notch organization from top to bottom.” - Senior Project Manager and Clinical Researcher
“Placing hard to find, adaptable people with very specialized backgrounds and a working knowledge of projects that are more complex to run is how The Evanston Group differentiates from others in the market.” - Clinical Manager specializing in rare disease
“My expectations were exceeded by the caliber of people The Evanston Group brings in. When I am looking for a special mix of talents, skills and background, The Evanston Group has been able to find and screen a very high quality set of resources. They are immediately right on target.” - Senior Vice President, $10B medical devices company
“It is rare when a company and its associates can exemplify so many wonderful values with forethought and respect for those in their employ.” - Software Engineer Consultant, Johnson & Johnson
Medical Device
Driving Value in the Laboratory
Clinical researcher highly skilled in rare diseases helps complete studies to submit for final FDA approval.
Our project teams and SMEs support clinical development (e.g.clinical trial physicians and clinical leaders building protocols) and clinical operations (e.g. study management and CRAs) to help drive even the most complex clinical studies.
We’ve helped clients respond to regulatory citations, remediate issues raised in 483 warning letters, and design and manage CAPA workstreams. We’ve also helped clients post-acquisition.
With deep experience in a range of pathways for pharmaceuticals and medical devices, our consultants provide regulatory support for both new product development and lifecycle management.
From manufacturing tech transfers to supply chain harmonization and beyond, we help life sciences leaders drive efficiencies, tackle challenges, and realize opportunities.
We provide project teams and PMO leaders with deep industry expertise and decades of experience accelerating delivery of key initiatives, from strategy to execution.
With project leaders (as high-level as IMO directors) and subject matter experts (including TSA experts, technology integrators, and specific workstream leads) we provide cross-functional divestiture and integration support.
We provide subject matter experts and cross-functional core team leadership for stage-gated development processes to support R&D from concept to commercialization.
For demonstrating value to healthcare providers and operationalizing KOL insights, we provide technology implementation and change management project teams as well as therapeutic area SMEs (including medical science liaisons and Phase 4 medical experts).
Our subject matter experts (such as product-specific solution architects) and project teams bring a holistic, disciplined approach to global software implementations (including ERP, PLM, CRO, PPM, and beyond) to ensure efficient, effective digital transformation.
Our Process
Share Your Need
Select Your Team
Get The Work Done
MEDICAL DEVICE, REGULATORY
Medical Devices and Their Complex Regulatory Environments
A five-month remediation project saves a global device firm $200 million in recalls and penalties.
