The MedTech
Growth Lab

The Fastest Way to Launch and Scale in the U.S. MedTech Market

A full-scale growth platform to help medtech companies enter and expand in the U.S. with end-to-end, white-label regulatory, operational, and logistics support to get your products approved, manufactured, and distributed faster.

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Mastering the U.S. Market:
A Deeper Look

The Problem

The Problem

Entering or expanding in the U.S. entails a complex mix of regulatory, operational, and market challenges, from stringent compliance requirements and fragmented supply chains to product-market adaptation and scaling constraints.

Many companies struggle to translate innovation into efficient, reliable operations while ensuring timely access to the market.

The Solution

The Solution

The MedTech Growth Lab guides companies throughout their growth journey, assisting with critical development, regulatory strategy and quality insurance. Once these foundations are set, The MedTech Growth Lab focuses on the operational, logistical and service support necessary for sustainable expansion.

We provide a seamless, end-to-end pathway to accelerate entry and expansion into the U.S. healthcare market.

Skills – Support – Service.

Here’s What We Can Offer Your Business

Two People Collaborating
Proven Industry Experience

We’ve helped organizations from around the globe succeed in the US market, maintaining regulatory compliance at every step.

Expertise
at Every Stage

With experts from a wide range of disciplines, our team has you covered at every stage of your business expansion process.

White-Label Services

We cover a wide range of turnkey, white-label solutions that work seamlessly for you and fly under the radar for your customers.

A Dynamic, Flexible Approach

Our customized solutions can be tailored to your organization’s unique needs at the drop of a hat.

Unparalleled
Network Access

Get access to our vast network of high-profile investors, vendors and other esteemed partners.

The MedTech Growth LabThe MedTech Growth Lab

  • Email/chat response services
  • Account management
  • Inbound & outbound calls
  • 24/7 access to client portal
  • Multilingual customer support via phone or email
  • Branding

  • Warehousing & storage
  • Fulfillment
  • Lot & batch control
  • Inbound/outbound
  • Transport management
  • Clearance of goods & documentation
  • Packaging configurations
  • Temperature controlled storage
  • Barcoding & RF barcode scanning

  • Full service consulting and advice for any operations needs

  • Payment collection
  • Order-to-cash

  • Tier 1, 2 and 3 technical phone support
  • Troubleshooting/repair/refurbish/testing
  • Calibration
  • RMA services
  • Preventative maintenance
  • On-site service visits

  • QMS establishing, management, improving and remediation activities
  • Design control Ops QA
  • Risk management & risk assessment
  • Supplier quality audits (internal, supplier, FDA, EUMDR, MDSAP, IVDR, GXP)

  • Facility/utility/equipment/device (IQ/OQ/PQ) V&V
  • Process, cleaning, sterilization, shipping validations
  • Computerized System Validation (CSV) software
  • Validation (SW)
  • Method Validation Test (TMV)

  • Regulatory strategy establishment (FDA, CE, MDSAP, etc.)
  • Communication with regulatory authorities
  • Design and development support
  • Clinical-regulatory affairs
  • Submission package preparation
  • CMC/BLA management
  • Gap assessment for new regulations

  • Clinical trial design and setup
  • Clinical study documents preparation
  • Regulatory submissions
  • Clinical monitoring & site management
  • Clinical QA
  • GCP training and auditing
  • Overall project management

  • New Product Introduction (NPI)
  • Scale up process
  • dFMEA & pFMEA
  • Product configuration
  • Statistical consulting
  • Streamlining of production lines (Lean Six Sigma)
  • Technology transfer

  • Sterilization
  • Biocompatibility expertise
  • Microbiology experts

  • Acting Chief Operations Officer

Establish Your U.S. Presence Instantly

For international companies entering the U.S. market, having a verified U.S. address and local phone number is the first step toward building trust and accessibility.

With The MedTech Growth Lab, you can:

Use a U.S. business address for official registrations, FDA communications, and customer correspondence.
Get a dedicated U.S. phone number answered professionally in your company’s name.
Have a U.S. email address (e.g., support@yourcompanyusa.com) managed by our trained team who respond as your local representatives.

You Run Your Business.
We Protect It.

ISO 9001

ISO 27001

ISO 13485

FDA REGISTERED FACILITY

PHARMACEUTICAL LICENSE

MANUFACTURING LICENSE

Our Licenses and Certifications Ensure:

  • Regulatory alignment and safe, effective medical device manufacturing

  • Compliance with strict health, safety, and quality standards in California and New York

  • Compliance with FDA regulations and quality system requirements

  • Customer satisfaction, efficiency, and continuous improvement

Meet the Powerhouses
Behind the Platform

Meet the team with decades of clinical, operational, and regulatory experience to give your MedTech company a competitive edge in the U.S. market.

Preferred Depot

Preferred Depot is an FDA-registered, ISO 13485:2016, and ISO 9001:2015 certified logistics and fulfillment partner. Preferred Depot’s white-glove service includes warehousing, assembly, reprocessing, customer support, and sales ops, all designed to plug into your operations and elevate your customer experience.

R.S NESS Group

A globally respected life sciences consultancy, R.S NESS Group provides end-to-end regulatory, clinical, engineering, and QA/QC services to accelerate compliant product development from ideation to market. With over 100 active clients, they are a go-to partner for MedTech innovation.

Highly-Trusted Across
Highly-Regulated Industries

Medical Device

IVD

Biotech

Digital Health

Medical Cannabis

Pharma

Want to Grow More?
Start by Knowing More.

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Ready to Turn Your Vision of US Market Success Into a Reality?