Compliance

Compliance

Medical Device Compliance

We combine deep regulatory knowledge with practical strategies to guide medical device development from concept through commercialization. Our consulting services are tailored to help navigate complex compliance requirements, implement effective quality systems, and manage product development with accuracy and confidence.

With a team of experienced industry professionals, MedLaunch is dedicated to turning medical device ideas into fully compliant, market-ready solutions. Explore our specialized services, designed to support every stage of the medical device lifecycle and uphold excellence from initial design to final market launch.

Solutions We Offer

ISO 13485: Quality Management
ISO 13485: Quality Management
21 CFR 820: FDA Quality System
21 CFR 820: FDA Quality System
EU MDR 2017/745 Compliance
EU MDR 2017/745 Compliance
ISO 14971: Risk Management
ISO 14971: Risk Management
IEC 60601: Medical Electrical Equipment
IEC 60601: Medical Electrical Equipment
IEC 62304: Software Development
IEC 62304: Software Development
IEC 62366-1: Usability Engineering
IEC 62366-1: Usability Engineering
ISO 10993: Biocompatibility
ISO 10993: Biocompatibility
Labeling, UDI, ISO 15223-1, 21 CFR 801
Labeling, UDI, ISO 15223-1, 21 CFR 801
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Experience Backed by Results

If you’re looking for an agile, fast-moving partner, MedLaunch is it. They have a unique ability to balance high-quality results with business and commercial requirements. I

Scott Nelson , CEO - Fastwave Medical

We have used MedLaunch for both regulatory consulting and verification and validation testing during the development and commercialization of our medical devices. MedLaunch provided succinct yet

Zach Copple , Founder/President - Paragon Surgical LLC

I am pleased to express my strong endorsement for MedLaunch, a pivotal partner in our journey towards regulatory excellence in the manufacturing of orthodontic appliances. As

Jim Aycock , VP of Sales, Marketing, and Business Development - G&H Orthodontics

I highly recommend Nathan and his team at MedLaunch. In an industry often marked by formality, Nathan's friendly demeanor and exceptional personality truly stand out. His

Troy Stites , Owner - Luminance Medical Ventures
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Real Solutions. Proven Results.

We don’t just talk about getting results; we deliver them. See how MedLaunch helps medical device companies overcome complex challenges and bring innovative products to market.

All Case Studies
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Revitalizing a Legacy Medical Device

Turning an Outdated Product Into a Modern Market Success

See How We Did It
Revitalizing a Legacy Medical Device
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Extending the Shelf Life of a Critical Medical Device

Solving Regulatory & Supply Chain Challenges to Keep a Life-Saving Product on the Market

See How We Did It
Extending the Shelf Life of a Critical Medical Device
Ready To Move Forward?

Every great device deserves a clear path to market.
Connect with MedLaunch today and take the first step toward approval and success.