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Your Medical Device Journey,
Simplified.

A truly great partnership. A client came to PLS with an incredibly well-designed device that would enhance wheelchair safety and performance. This device adds machine learning technology to guide wheelchairs, providing unparalleled stability, security, and connectivity through cloud-connected software and hardware mounted between the seat and wheels. The client’s device prevents tips, collisions, and falls, ensuring a safer and more inclusive experience for mobility wheelchair users.

A true grit story. Several years ago, a client came to PLS with an extremely innovative system of surgical tools for disc nucleus replacement. The client designed each tool for each stage in the surgical steps so the physician would have everything needed in one kit to perform the procedure. We worked alongside our client to develop user requirements and specifications under ISO 13485:2016 and 21 CFR 820 (FDA QSR) regulations. Our client decided to submit for CE marking first.

At Prospect Life Sciences (PLS), we partnered with a client to transform their innovative catheter device from concept to market. Initially designed by another firm, the device did not meet safety, performance, manufacturability, and regulatory standards. PLS identified the need for complete redesign and provided comprehensive support, including product feasibility and modeling services. We developed detailed design specifications, usability requirements, prototype demos, and conducted rigorous engineering testing.

I have worked with PLS on several development efforts over the last year, and they have been a pleasure to work with throughout. I’ve been impressed with their team’s broad experience and proven ability to support early-stage medical device companies across all aspects of development. I especially value their hands-on approach—providing guidance when needed, responding quickly to requests, and clearly communicating project performance and expectations. Their structured project management and dedication to deliverables have been key in keeping our projects

I cannot overstate how much our company has appreciated Prospect’s contributions and/or the level of expertise they provided. We utilized Prospect in the areas of: V&V of a novel and innovative dental instrument, Quality System development and improvement, and design for manufacturing considerations. I would  turn again to Prospect without hesitation for help evolving our product lines and technology. It is also without hesitation that I recommend others turn to Prospect for similar and likewise help and consultation. Prospect’s vast product development experience and understanding is outstanding

Prospect Life Sciences helped guide our product development process. They have a proven track record working with complicated medical devices including long term implants. Their robust quality system and SOPs helped to dramatically accelerate our development. Their flexibility, responsiveness, and depth of knowledge make them an ideal partner. In partnership with the PLS team, we took our spinal implant product from early development to clinical trials to CE mark under budget and on-time.

We selected Prospect Life Sciences to assemble and ship our liver diagnostic kits because they bring strong customer focus to their processes. As a company seeking FDA approval of our tests, we needed a partner who could deliver quality, responsiveness, and process transparency. PLS has exceeded our expectations in each of those areas and we’re pleased to bring part of our supply chain back to Colorado.

We chose PLS to help guide our new product introduction and development. They have a proven track record working with complicated electro-medical devices and their robust quality system helped to dramatically accelerate our development program. Prospect streamlined the process from design inputs to V&V testing to production and used their extensive experience with risk analysis to help us avoid potential pitfalls. Their flexibility, responsiveness, and depth of knowledge make them an ideal partner.

As a University spin-out, we needed a medical device development and manufacturing partner that was flexible and able to meet our needs first in proof of concept development, and ultimately in product validation. Prospect understood our goals and helped us achieve them even more efficiently than we’d hoped.”
Dr. Mark Rentschler

As a start-up company with a product in the early stages of development, Prospect’s ability to quickly adapt to changes was instrumental in ensuring key milestones were met. The PLS team was personally invested in the success of our project, and always ready with solutions for overcoming challenges. Prospect’s wealth of medical device development and manufacturing experience was an invaluable resource in setting up our pilot manufacturing line.