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JALEX Medical: Successfully Taking Medical Devices from Ideation to Fruition

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Jennifer Palinchik, President

The medical device industry landscape is drastically shifting with the rise of connected and software-driven medical devices. Owing to the combination of innovation, quality hardware, and software, these devices have undoubtedly become highly sophisticated. The evolution in the industry has also resulted in the emergence of newer standards and regulations, making compliance procedures all the more complex. Another setback for most medical device companies is the lengthy process of documentation to receive the FDA approval for the products to go to market. To this end, JALEX Medical, a privately-held product development and regulatory firm based out of Ohio, has successfully positioned itself to help clients take their innovations from concept to commercialization with ease. The company offers product development, design engineering, regulatory affairs, and quality management solutions along with the expertise of its biomedical engineers to support clients through every stage of the development process. “We’re committed to building relationships based on trust while providing exceptional value to our clients through our services,” begins Jennifer Palinchik, the President of JALEX Medical.

JALEX Medical caters to startups, small and large business, and healthcare and academic enterprises that require engineering and regulatory support. Most of its clientele include medical device companies, hospitals, surgeon inventors, and research institutions. Often, these clients lack efficient internal resources to accomplish their commercialization goals. For startups, JALEX Medical offers extensive education with step-by-step directives required to take their products from ideation to commercialization.

“We provide a variety of engineering and regulatory activities from 3D modeling concepts, prototyping, regulatory pathways, testing requirements, submissions to the FDA, and also post-market surveillance to our clients,” adds Jennifer.

We always have and will continue to put our best foot forward to get innovative products to market sooner by continuously partnering with our clients

JALEX Medical assists with the verification and validation processes, ensuring the performance and safety and effectiveness of the product meets FDA requirements. This process includes design control documentation, risk assessments, sterilization and packaging, mechanical testing, and process validation.

Additionally, the experts at JALEX Medical assist clients in meeting the standards of regulatory agencies to acquire market clearance for their products. These activities include regulatory strategies, pre-submission meeting documentation and support, 510(k) submissions, and interactive reviews.

Acting as an extended engineering and regulatory department, JALEX Medical also offers support services. Often, companies opt for short term initiatives, where they look to create and commercialize their products relatively quickly. In such cases, clients choose the team of JALEX Medical to expedite product development, rather than hiring full-time employees.

JALEX Medical has partnered with several clients in the surgical devices arena, helping them with product development and receiving clearance for implants.. With several remarkable feats in the product development of a myriad of devices, including surgical navigation devices, implants, orthopedic equipment, among others, JALEX Medical has established a stronghold in the medical device manufacturing field. “We continue to grow from both a resource as well as a product and capabilities standpoint steadily. We always have and will continue to put our best foot forward to get innovative products to market sooner by continuously partnering with our clients,” concludes Jennifer.

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Company
JALEX Medical

Headquarters
Westlake, Ohio

Management
Jennifer Palinchik, President

Description
JALEX Medical offers product development, design engineering, regulatory affairs, and quality management solutions along with the expertise of its biomedical engineers to support clients in the medical device industry through every stage of the development process.. The company provides step-by-step directives to startups to take their product from ideation to fruition. It works on the process of 3D CAD modeling, finalizing the materials and the manufacturing process, and then prototyping the product for client approval. It further works on the verification and validation process, after which it helps clients acquire clearance on their products to go to market. JALEX Medical works as an extension of the clients’ engineering and regulatory department while supporting them throughout the roll-out process