AN INDUSTRY LEADER IN

Medical Devices

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.
read CASE STUDY

Areas of Expertise

Clinical

Project leader expertise to support clinical phases 1–4 across trial design and execution; pipeline/portfolio management

Quality Assurance & Control

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.

Regulatory

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.

Manufacturing & Engineering

Site separation and relocation, supply chain sourcing, raw material and API development, validation of new lines from CMO partners as well as product expansion, CMC management, launches

Supply Chain

The pharmaceutical and med device industry is navigating major upheaval. We connect the lab to the marketplace managing track and trace, serialization, and auditing/managing suppliers.

Mergers & Acquisitions

Strategy planning for mergers, separations, divestitures and transformations, including labeling changes, training and sales and reporter integration.

Research & Development

We provide subject matter experts and cross-functional core team leadership for stage-gated development processes to support R&D from concept to commercialization.

Product management

The product vision with deep industry knowledge that will help you drive key initiatives.

Digital Transformation

Build next generation enterprise tools to solve problems and advance your innovation agenda.

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.
read case study

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When you need experienced leadership, rapid response, and exactly matched talent, call on The Evanston Group.