Incubator services for MedTech startups with cleanroom rental, QMS support, DHF development, and UDI compliance in FDA-registered, ISO-certified facilities.
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.
For early-stage medical device companies, access to a certified cleanroom facility is crucial for product assembly, testing, and compliance. LSO offers:
Developing and maintaining a compliant QMS is essential for medical device approval and market entry. LSO provides:
A comprehensive Design History File (DHF) is required to demonstrate compliance with FDA and ISO regulations. LSO supports:
Support for submission-ready technical documentation
Unique Device Identification (UDI) compliance is a critical requirement for medical device commercialization. LSO assists in:
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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