Life-changing devices deserve proven expertise

PTL Solutions offers a unique blend of experienced experts and leaders in every speciality for successful MedTech product development.

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Our Services

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Regulatory Affairs

Develop regulatory strategies, secure designations, and manage submissions with FDA, Health Canada, EU MDR, and international agencies.

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Quality Management

Build clear, compliant QMS frameworks aligned with global standards like ISO 13485, ISO 14971, IEC 62304, MDSAP, and EU MDR.

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Clinical Evidence

We deliver clinical trial design, regulatory, and evidence generation expertise to drive biotech and life sciences success from concept to market.

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Go-to-Market

We support market entry and clinical adoption through strategy, workflow analysis, training, and data-driven product positioning.

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Product Development

We drives MedTech development with integrated hardware, software, and regulatory support, ensuring compliant, market-ready products.

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Human Factors

We delivers expert Human Factors and Usability Engineering services to ensure medical devices are safe, intuitive, and meet regulatory standards.

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About Us

Turning expertise into your fastest path to market.

PTL Solutions Inc. is a team of senior level medical device consultants with 100’s of years of experience who have brought 100’s of devices to market across the globe.

We have led programs across all classes of devices in all regions around the world. We bridge strategy and execution, providing both leadership and hands-on support to accelerate development while avoiding costly pitfalls.

Our goal is to provide solutions and results quickly, leaving behind a newly minted team of experts.

Testimonials

What Our Clients Say

“PTL has been instrumental in getting our development activities back on track. When they began working with us, they quickly assessed our situation, knowing precisely the right questions to ask. They had great feedback and impactful suggestions for how to move forward in the most productive and expeditious manner.

On top of their superb technical and industry expertise, they ares a delight to work with. I have no hesitation heartily recommending PTL Solutions Inc. to any other medical device company.”

CEO

“When supporting the upgrade of a design control system, PTL Solutions helped quickly and effectively identify gaps. Through leveraging their superb knowledge of FDA expectations and recurring industry struggles, they quickly offered specific, actionable, and insightful feedback.

PTL Solutions went beyond simply identifying problems and proposing solutions, as they quickly generated documentation that was seamlessly integrated, and served as excellent examples for internal staff to learn from. In all matters, PTL acted with speed, professionalism, and an authentic understanding of client needs.”

Director

“PTL Solution’s deep understanding of the medical device industry, combined with their strategic insights, allowed us to map out a clear and effective regulatory path.

Through their extensive connections within the industry, they introduced me to key stakeholders, experts, and potential partners. Their introductions opened doors, allowing us to establish meaningful relationships that have been crucial to our success.

Their expertise, vast network, and genuine commitment to client success make them an invaluable partner in the challenging world of medical device development.”

CEO