A Clear Difference

in What We Coat For You

Focused on Coating

Proven contract manufacturing expertise with
difficult materials for your challenging needs

Focused on You

We specialize on meeting your needs through
custom medical device coating services

Focused on Performance

We are one company offering many technologies
for any medical device coating challenge

Focused on Value

Designed and scaled for excellent service and pricing.

Formacoat LLC partners with customers who choose to focus on their core competencies and seek to minimize the internal expense associated with hydrophilic and hydrophobic coating operations. We build a direct, personalized relationship with each client, drawing upon our expertise and array of different vendors to skillfully meet your biomedical and niche industrial coating needs.

Does Your Medical Device Need a Coating?

Our advanced capabilities and responsive service hit the device coating bullseye.

With coating types from many different vendors, their different chemistries and technologies provide us a wide range of types of coatings, materials to coat, and biomedical functionalities to offer. Working with just Formacoat simplifies your search for the best coating for your product.

In short, we make your coating development project "Run Smoother."

At Formacoat:

Our experts in contract manufacturing coating services work to find the right coating for your device. We then develop the process to apply that coating for our commercial coating services. Our expertise allows you to focus on your core skills, while we help you make the transition to commercial sales simple and effective.

Making the Tools of Medicine Run Smoother^®

How can we help you "Run Smoother" today?

Get Focused on

an eye for expertise!

Call or Email Formacoat Today.

952.895.0200

info@formacoat.com

Sponsored By

05/22/2024 22:08:13

in this issue

ISSUE 25 // MARCH 2020

in this issue

issue 25 // MARCH 2020

It’s been little over a century since plastic surgery emerged as a treatment for wounded soldiers in WWI. While the general concept remains the same, technology has completely revolutionised the possibilities of reconstructive surgery. To find out more, we explore the arsenal of sophisticated systems and devices being used in plastic surgery.

Also in this issue, we examine a new adhesive that could replace traditional sutures, explore efforts to improve access to women-specific medical innovations in Asia, and review a new technique that allows researchers to 3D print living skin complete with blood cells, which could transform skin grafts.

Plus, we investigate the potential of deep brain stimulation in the treatment of mental illness, dive into the complex subject of regulating medical devices in India, and debate plans to have newborns in the UK receive whole genome sequencing at birth.

Finally, we find out how the US FDA plans to rehabilitate non-compliant device manufacturers, and get the latest insight, innovation trends and analysis from GlobalData.

Eloise McLennan, editor

05/22/2024 22:08:14

YOUR PARTNER FOR INTERNATIONAL REGULATORY COMPLIANCE

MANAGEMENT, DEVELOPMENT & CONSULTING FOR MEDICAL DEVICES

Are you prepared for the IVDR?

NSF’s IVD App Coming Soon

The upcoming IVDR introduces major changes for manufacturers placing devices on the European market, including changes to device classification, requirements for technical documentation and clinical evidence, and new obligations for economic operators.

Take a look at some of our resources to help you prepare, they include a tool to compare IVDD and IVDR requirements, a white paper explaining IVDR safety and performance requirements and a webinar presenting preliminary templates for writing performance evaluation reports.

The best place to stay up to date with the latest IVD regulatory updates – access our library of free resources, contact our industry experts and enroll in our eLearning.

White Paper: Exploring the Relationship Between the IVDR and the IVDD

White Paper: The GSPRs - The Heart of the EU IVDR

Webinar: In Vitro Diagnostic Regulation (IVDR)

Are You Facing a Complexity Crisis?

Martin Lush explains the costs of over-complexity and the true root causes. It also includes a self-assessment questionnaire for you to discuss at your next team meeting.

>> Read the White Paper

Implementing a Simplification Strategy

This webinar from Jim Morris reviews three essential simplification strategies that site leadership and unit operations managers can pursue.

>> Watch the Webinar

How to Jumpstart Your Pharma Business by Simplifying Processes

Making processes simple underpins GMP compliance as complexity is the catalyst for error and deviation. John Johnson shares how we use simple processes and a course toolkit to enable your team to begin the process of refinement, clarification and error proofing.

>> Watch the Video

Fix SOP Complexity

In this short video, Martin gives his insight into how much detail we should put in a SOP to avoid overload, explaining what you should leave in and what to take out.

>> Watch the Video

A Beginner’s Guide To Quality Risk Management (QRM)

The pharmaceutical industry approach to assessing and controlling quality risks has largely been empirical. This is often fine but in more complex or hazardous situations, the pharmaceutical industry could benefit from a number of very helpful tools and techniques.

> > Discover more

For more information on our medical device services contact eudevices@nsf.org or visit our website.

05/22/2024 22:08:14