What We Do

With over 100 years of combined experience in healthcare, Masek Medical delivers world-class solutions crossing a wide range of disciplines.  We provide clients of all sizes with the tools, processes and solutions which drive innovation, efficiency and profitability.

Medical Devices

Product Design V&V

510(k) Filings

ISO Certification

FDA Audit Prep / Remediation

International Submissions

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Operational Excellence

Process Validation

Lean Techniques

Accurate Costing

Continuous Process Improvement

Statistical Process Control

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Market Research

New Product Development

Business Case validation

Messaging & Collateral

Financial Proformas

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Masek Medical provides insightful and effective solutions which help our clients lower costs, increase productivity, enhance portfolios, overcome regulatory hurdles and increase shareholder value.


We have a proven record of innovation in the fields of patient care, healthcare sustainability and digitization of medical records.


Our experience, creativity and fierce passion for the enhancement and advancement of healthcare results in the rapid conversion of our clients’ ideas into tangible and viable commercial models. 

Medical Solutions

Bringing Med-Tech and Innovation to the Forefront


With the top minds in the industry, Masek Medical uses years of industry knowledge and state-of-art innovation to bring technology to medical providers. Our solutions can lower costs, as well as increase effectiveness, and productivity across the board.

Masek Medical will guide you through the whole process from product development, equipment design, to getting the necessary certifications.

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Let Masek Medical guide you to the next step

Book a Free Consultation and let Masek Medical guide your business to the forefront of Medical Technology and Innovation.


Developed reprocessing capability for world leading manufacturer, including the construction of a state-of-the-art greenfield site in Riverview, FL

Generated validation data for the obtainment of a reprocessing 510(k) for compression sleeves within 9 months.

Obtained 510(k) for novel femoral implant which eliminated need for cortical screws.

510(k) for radiofrequency ablation catheter

Provided guidance for disinfection and aseptic processing for an innovative oximetry device

Created custom application to manage the sorting process for Vanguard’s medical device value capture & recovery program

Validated surgical instrument washing system

Wrote web-based quality and operations systems, eliminating paperwork, streamlining processes and optimizing software development lifecycle for core hardware

Provided sterilization validation guidance based upon the complex nature of mixed loads

Wrote data acquisition software for sterilization equipment which harmonized analysis across equipment qualifications

Medical Technology Solutions


Masek Medical is able to deliver world-class results for our clients by leveraging our breadth of experience, depth of technical know-how and an unrelenting passion for excellence in all that we say and do.

Seth Masek

President & CEO

Seth Masek

President & CEO

With a passion for entrepreneurial enterprises, Seth has been on the cutting edge of the med tech sector including the formation and validation of single use device (SUD) reprocessing, digitization of healthcare and creation of novel orthopedic implants.  He has held leadership roles within R&D, Operations, Quality, Regulatory, Sales and Marketing.  Having broad experience in businesses large and small, Seth works relentlessly to deliver consistent, successful outcomes for his clients and their interests.

Nicole Riegler

Chief Financial Officer

Nicole Riegler

Chief Financial Officer

Bringing 15+ years of manufacturing, finance and business management experience from one of the world's largest med tech companies, Nikki has a proven track record of success. Her ability to rapidly solve complex problems with elegant, cost effective solutions makes her extremely valuable for organizations looking to responsibly and sustainably grow their business. She is a driver of results and an activator of individuals making her ideally suited for cross functional, creative problem solving.

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