Medical Device Incubator Services

Incubator services for MedTech startups with cleanroom rental, QMS support, DHF development, and UDI compliance in FDA-registered, ISO-certified facilities.

Accelerating Medical Device Development & Compliance

Bringing a new medical device to market requires specialized facilities, regulatory expertise, and a strong quality management framework. At Life Science Outsourcing (LSO), we provide end-to-end medical device incubator services, designed to support early-stage MedTech startups and emerging medical device companies.

From cleanroom rental and facility utilization to regulatory documentation and UDI system implementation, our incubator services help streamline commercialization, reduce costs, and ensure compliance with FDA, ISO 13485, and UDI regulations.

Need expert support for medical device development?

Comprehensive Medical Device Incubator Services

Cleanroom Rental & Facility Utilization

For early-stage medical device companies, access to a certified cleanroom facility is crucial for product assembly, testing, and compliance. LSO offers:

ISO Class 5-8 cleanroom rental for device development & manufacturing
Fully equipped facilities with packaging, sterilization, and testing services
Cost-effective solutions for startups without requiring capital investment in infrastructure

Quality Management System (QMS) Coverage

Developing and maintaining a compliant QMS is essential for medical device approval and market entry. LSO provides:

ISO 13485-compliant QMS framework development
Regulatory documentation and compliance support
Process validation, risk management, and CAPA implementation

Device DHF (Design History File) Development

A comprehensive Design History File (DHF) is required to demonstrate compliance with FDA and ISO regulations. LSO supports:

DHF creation and documentation for FDA 21 CFR Part 820 compliance
Design control procedures and risk management integration

Support for submission-ready technical documentation

UDI System Implementation

Unique Device Identification (UDI) compliance is a critical requirement for medical device commercialization. LSO assists in:

UDI labeling and data management compliance for FDA and EU MDR
Integration of UDI tracking into supply chain & regulatory submissions
GS1 and HIBCC-compliant barcode and serialization implementation

Why LSO?

FDA-Registered, ISO 13485-Certified – Ensuring compliance with the highest industry standards
End-to-End Manufacturing & Assembly – From prototyping to full-scale production
Bicoastal & Nearshore Operations – Facilities in California, New Hampshire, and Costa Rica for cost-effective, scalable solutions
Quick-Turn Services – Faster sterilization, validation, and lot release to accelerate market entry
Proven Expertise in Medical Devices – Supporting orthopedics, neuromodulation, cardiovascular devices, and more