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Hardware Development

MedTech- Hardware Development

At TechFlex, we specialize in providing cutting-edge hardware solutions for the medical device industry.

Software Development

MedTech- Software Development

In the ever-evolving landscape of the medical device software development solutions.

Regulatory

Ensuring that medical devices meet stringent regulatory standards and are secure against cyber threats.

Empowering Startups in Series A and Seed Money Stages

How TechFlex Works with Startups

TechFlex is dedicated to assisting startups in the Series A and Seed money stages to achieve their objectives through a structured and supportive framework. Our approach focuses on providing tailored solutions that address the unique challenges faced by early-stage companies.

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Empowering MedTech Growing Companies Innovators

Transforming Visions into Market-Ready Solutions

TechFlex is the catalyst for success in the medical device industry, offering comprehensive support to growing companies. With expertise spanning from initial concept to market entry, TechFlex provides tailored solutions, cutting-edge technologies, and regulatory guidance.

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Solve What?

Accelerating Time to Market

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Handling Complex Development

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Accelerate your MedTech

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Ensuring Regulatory Compliance

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MedTech Cost Saving

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Applications

Wearable Technology

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Healthcare Management

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Invitro Diagnostics

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Cryoablation

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Microfluidics

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Optics

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Wireless

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Ultrasound

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RF Generation

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Resources/ Blogs

Blog And Resources

Insights and Resources

TechFlex Team

This combined approach allows TechFlex-Dev to offer cost-effective solutions without compromising on quality. By minimizing the need for heavy capital investments in specialized equipment and personnel, we help manage your budget more effectively. Our development processes are meticulously designed to align with regulatory standards, ensuring your medical devices are compliant, reliable, and market-ready.

Jorg Lorscheider

CEO

25 years experience leading engineering service companies.
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Anna Suchard

COO

20+ years software quality assurance and management.

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Shepard Bentley

VP Regulatory Affairs

25+ years quality management and regulatory consulting.

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Alexandra Barsukova

VP Engineering

Engineering management for over 11 years.
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TechFlex-Dev optimizes cost management by leveraging a dual-location strategy. Our project management and account leadership teams are based in the USA, providing seamless communication, alignment with your time zone, and strategic oversight. This ensures that your projects are managed efficiently and meet all regulatory standards, including FDA and ISO requirements. Meanwhile, our highly skilled development teams operate out of several locations in Eastern Europe. This strategic distribution allows us to tap into a pool of top-tier engineering and development talent at significantly lower costs. Eastern Europe offers a competitive pricing structure due to lower operational costs while maintaining high performance and quality standards.

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Founded with the vision of revolutionizing medical device development, TechFlex-Dev combines years of industry experience with a passion for innovation. Our mission is to deliver high-quality, compliant, and effective medical devices that improve patient outcomes.

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Jorg Lorscheider

CEO

Jorg has been a key leader and board member in the engineering services industry for many years, He has managed and executed all aspects of the business over the years, including Strategy, HR, Business Development, Finance, IT, and Engineering. Jorg is also very active in the medical startup community and has been an advisor to countless startups. Jorg is also chairman for the IVD Linkedin group. His passion is seeing medical developments succeeding to help patients.

PERSONAL: Jorg advises and invests in technologies, Enjoys time with his grown children, Is currently living in Orange County CA and Highland County VA.

HISTORY: Jorg was formerly a world class volleyball player having played for UCSB, USA Jr National Team, USA National Team, and professionally at Thermomec Spa, Padova Italy.

Publication
Patents: US5697811 A
US6077108 A

Anna Suchard

COO
Anna is an entrepreneur with over 20 years of hardware and software development experience. Anna has a thorough understanding of the entire software development life cycle (SDLC) and thus is instrumental in managing our development projects. Anna has extensive experience in creating and managing remote teams and is key to our relationships with our customers and remote teams. Anna has held roles with Dynamic Healthcare systems, CompuGroup Medical, Merge Healthcare, OIS, GE Healthcare, Intel, Given Imaging, and Biosense Webster (Israel).
PERSONAL: Anna lives in Newport Beach with her family. She travels frequently, managing her various business interests.

Shepard Bentley

VP Regulatory Affairs
Shep has guided dozens of companies through the regulatory process and secured clearances in the USA, Europe and Asia. His background in development and manufacturing has given him a view of the entire development process and how quality systems and regulatory compliance intertwine throughout. As a former Lieutenant Colonel in the Marine Corps, Shep enjoys the structure and dynamic nature of the product development, manufacturing and regulatory process. Shep has consulted on regulatory and quality matters for a wide range of companies over the years, including Amgen, Actus Biotech, AfectaPharm, AscentX, BBraun, BioClynse, Biofield, Borimed Pharma, C5, Convoy Biotech, Dental Sciences, EndurX Enteron, HeartHero, ImmutriX, Johnson & Johnson, K18 (Unilever), Pathelen Health Care, Pharmakos, Primal Critical Care, Secant Pharma, Sona NanoTech and many others.
PERSONAL: Shep lives in Laguna Niguel CA Travels frequently to Portugal to visit his family. Shep served in Desert Storm, and Iraq for Enduring Freedom.

Alexandra Barsukova

VP Engineering
Alexandra is our key point of contact with our Eastern European teams. She manages a staff of ~60 engineers to get our engineering and design projects completed on time and on budget. Alex is also an entrepreneur who understands every aspect of the business and how to best staff and control costs within our programs. Her background from being with the Ukrainian research institute for manufacturing engineering gives here a strong experience in how products are not only designed, but also manufactured. Alex also worked at United Engineering, Mobindustry Corp, and startup called Branto. Alex is multidimensional in that she has a deep understanding of electronics, Mechanical engineering as well as firmware and software engineering.
PERSONAL: Alex lives in Dnipro, Ukraine with her partner, son and dog Aston-Martin. She travels to the US yearly to meet with us and our customers.
PUBLICATIONS: Alex Routledge Handbook of Risk Management and the Law; Chapter 23: Quality Management Considerations Routledge / Taylor & Francis Group (New York and London) March 2, 2023
Medical Device Book Internet Of Things for Medical Electronic Device Solutions (MEDS) 1st Ed. June 15, 2015; 2nd Ed. September 15, 2020
Medical Device Labeling: A Universe of Confusion J AMWA vol 34 no 4
So, you think you know about medical devices? J AMWA vol 34 no 2
Finding a Balance in the Assessment of Risk; Genetic Engineering & Biotechnology News (GEN) March 3, 2006 vol 26; no 3

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