Life-changing products deserve proven expertise
The PTL Solutions team has leveraged their MedTech expertise to help bring dozens of products to market and help improve the lives of millions of patients.
REGULATORY AFFAIRS
PTL helps customers begin strategizing early and often. We can quickly and efficiently help our clients complete:
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Regulatory strategies
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Specialized designation applications - Breakthrough, Safer Technologies
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Meetings request with Regulatory Agencies
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Regulatory Submissions with FDA, Health Canada, EU (MDD to MDR), and Asia
QUALITY MANAGEMENT SYSTEM
PTL Solutions has extensive experience developing comprehensive QMS with processes that comply with:
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21 CFR part 820
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ISO 13485, ISO 14971, ISO 62304
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MDSAP
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EU Medical Devices Regulation MDR 2017/745
We ensure procedures align with regulations and standards and are easy to understand. This helps ensure they are properly implemented by staff.
PRACTICAL ALIGNMENT:
REGULATORY AFFAIRS AND QMS
PTL highlights to clients the importance of aligning regulatory strategies and quality management processes.
Our team has a extensive experience modifying established QMS to comply with additional regulations, standards and guidance documents.
Our experience and expertise, along with our holistic philosophy makes us the perfect team to lead MDD to MDR transition, MDSAP implementation, and general alignment with new or revised regulatory documents.
QMS IMPLEMENTATION AND EXECUTION
PTL Solutions Inc. provides templates and tools for educating staff and expediting the completion of documentation activities, such as:
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Design History Files, Device Master Records
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User Needs and Intended Uses
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Design Inputs and Design Outputs
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Design Verification and Validation
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Risk Management
Our goal is to teach staff using a learn by doing philosophy, in the hopes of creating in-house experts, and setting our customers up for continued success when we're gone.
PTL guides manufacturers seeking to commercialize by developing strong marketing and launch plans, go-to-market strategies, competitive analysis and pricing models. We lead the charge for adopting new technology.
TESTIMONIALS
GET IN TOUCH
We serve customers from across the globe!
+1-438-680-8634
ABOUT US
PTL Solutions Inc. is a team of senior level medical device development consultants with nearly 80 years experience who have supported bringing over 50 devices to market across the globe.
We use our experience, along with a strong understanding of data made available by regulatory agencies, to bring our customers well thought out and relevant solutions.
Our goal is to provide solutions and results quickly, leaving behind a newly minted team of experts.