JAKTALK

JAKTOOL Engineered Solutions is ISO-13485 Certified


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In this episode of JAKTALK, host Jeff Kinsberg sits down with Cristy Richards, President and CEO of JAKTOOL, to discuss the company's recent achievement of ISO-13485 accreditation. This globally recognized certification marks a significant milestone for JAKTOOL, allowing the company to expand its offerings and support clients in bringing their MedTech innovations to market.

Cristy and Jeff delve into the importance of this accreditation for the MedTech community, exploring how it helps de-risk product development and streamline the journey from prototype to production.

They also discuss the challenges of transitioning ideas through the "Valley of Death," the complexities of regulatory approval, and JAKTOOL's continuous improvement culture.

Whether you're in the MedTech industry or simply interested in quality management systems, this episode offers valuable insights into the processes that ensure product safety, efficacy, and market readiness.

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  • www.jaktool.com/


About us:
Our niche: Developing products and accelerating them to market, so let's build something great together!

JAKTOOL has grown over 25 years into one of the Northeast's premier product development, engineering, and precision prototyping and contract manufacturing companies on the merits of our passion, talent, and dedication. JAKTOOL is your trusted product development and manufacturing partner.

  • We are a team of humble engineers, craftsmen, and program managers who love interesting and unique problems.
  • We help mature ideas into physical prototypes for faster transition and provide low-volume production for precision parts that are difficult to source.
  • We excel at projects that are too precise and low volume for most shops.
  • We outperform most engineering design firms that get lost in CAD and create virtual models that cannot be built or verified.
  • We can physically fabricate and inspect most of the mechanical and electrical products and systems that we design in-house.
  • We have an unbiased process (AIM) to consistently capture functional requirements and develop a material solution to transition into production.

Let's work togethe...

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