Medical Device Incubator Services | ISO 13485 Infrastructure
Medical Device Incubator Services with certified cleanroom access, ISO 13485 infrastructure, and FDA registration support for startups moving to production.
Cleanroom Access and Quality Infrastructure Without Building Your Own Facility
You have a device that works.
What you don’t have is a cleanroom, a validated manufacturing environment, or an established quality system — and your timeline does not allow you to build one from scratch.
LSO’s Medical Device Incubator Service provides facility access, ISO 13485 infrastructure, and regulatory guidance so you can move from development to production without capital-intensive buildout
Infrastructure Without Capital Expenditure
Building your own manufacturing facility requires:
- Cleanroom construction
- QMS implementation
- FDA registration
- Validation planning
- Experienced manufacturing leadership
LSO provides:
- Use of certified cleanrooms
- Office space with a physical address
- ISO 13485-certified manufacturing infrastructure
- Quality management system development support
Rather than diverting capital to build cleanrooms and implement a quality system, you operate within an established ISO 13485-certified manufacturing environment.
Regulatory Alignment from Day One
Manufacturing decisions made early affect regulatory timelines later.
The incubator program supports:
- FDA registration support
- ISO and FDA audit readiness
- Sterilization and package validation alignment
- UDI implementation guidance
Quality infrastructure is not added after the fact. It is built into the production environment from the start.
Clinical, R&D, and Early Production Builds
Startups often need structured manufacturing support before full commercialization.
The incubator model supports:
- Clinical and R&D builds
- Early production runs
- Packaging and validation support
- Full traceability within an established
This creates a practical path from “working prototype” to “regulated production.”
Startups generally do not have space or cleanrooms to perform medical device sample production. That’s where Life Science Outsourcing can help. We’re committed to helping medical device manufacturers find the answers and solutions they need to bring their innovations to life quickly and efficiently.
OEMs Seeking Surge CapacityStartupsResearch & Development Teams
- Immediate cleanroom access: Class 7 (Class 5 pharma) cleanroom space available for short-term production needs.
- Scalable solutions: Manage seasonal demand or unexpected production surges with ease.
- Cost-efficient flexibility: Avoid delays and high capital investments with flexible rental options.
- Support for new launches: Perfect for accelerating new product introductions to the market.
- Expert resources: Advanced tools and engineering expertise ensure consistent product quality.
- Turnkey production space: Immediate access to Class 7 (Class 5 pharma) cleanrooms for prototypes or small-batch runs.
- Regulatory-ready environments: Build under FDA-compliant conditions without costly investments.
- Streamlined operations: Focus on innovation while we handle operational complexities.
- Scalable as you grow: Adaptable solutions for transitioning from pilot runs to full production.
- Guided expertise: Access to engineering staff to support your product development journey.
Research & Development Teams
- Controlled environments: Conduct critical testing and feasibility studies in ISO-certified cleanrooms.
- Short-term flexibility: Secure rental options tailored to R&D project timelines.
- No minimum build requirements: Ideal for small-scale runs or early-stage prototypes.
- Cost-effective experimentation: Avoid the need for long-term facility investments.
- Streamlined workflows: Leverage cleanroom setups to maintain efficiency during clinical builds.
- End-to-end support: Partner with experienced teams to ensure smooth project execution.
Class 7 cleanroom, medical device manufacturing, cleanroom facility, small-lot production, prototyping space, sterile environment, cleanroom rental.
Class 7 cleanroom, medical device manufacturing, cleanroom facility, small-lot production, prototyping space, sterile environment, cleanroom rental.
Class 7 cleanroom, medical device manufacturing, cleanroom facility, small-lot production, prototyping space, sterile environment, cleanroom rental.
Class 7 cleanroom, medical device manufacturing, cleanroom facility, small-lot production, prototyping space, sterile environment, cleanroom rental.
Class 7 cleanroom, medical device manufacturing, cleanroom facility, small-lot production, prototyping space, sterile environment, cleanroom rental.
Class 7 cleanroom, medical device manufacturing, cleanroom facility, small-lot production, prototyping space, sterile environment, cleanroom rental.
Class 7 cleanroom, medical device manufacturing, cleanroom facility, small-lot production, prototyping space, sterile environment, cleanroom rental.
A Proven Environment for Innovators
OEMs Seeking Surge Capacity
Startups
LSO cleanroom access is designed to support medical device and regulated life science applications that require controlled environments, particulate control, and ISO-aligned quality systems. The following guidance helps determine whether your product is a good fit.
Medical devices (sterile & non-sterile)
Core use case
Single-use disposable medical devices
Assembly and packaging supported
Catheters, tubing, fluid paths
Medical-grade handling
Wound care products and dressings
Pre-sterilization workflows
Medical kits and procedure trays
Kitting and packaging supported
Sterile barrier packaging assembly
Sealing, inspection, and preparation
Diagnostic device components (non-reagent)
Hardware and consumables only
Medical device subassemblies
Particulate-controlled assembly
Pharmaceutical / drug manufacturing
Requires pharmaceutical GMP infrastructure
Drug formulation or compounding
Outside LSO’s regulatory scope
Aseptic fill-finish operations
Not a CDMO
Cosmetics or personal care products
Different regulatory and cleanliness requirements
Food, beverage, or nutraceutical products
No regulatory or operational overlap
Biological or biohazardous materials
Requires BSL-rated facilities
Live cell, tissue, or microbial handling
Not compatible with cleanroom design
Cleanroom Access — Product Compatibility
Products That Work Well in LSO Cleanrooms
Suitable ApplicationsNotes
Products Not Supported in LSO Cleanrooms
Not SupportedReason
Designed to Scale With You
LSO Incubator Support is not a short-term rental model.
It provides:
- Facility utilization options
- Access to experienced manufacturing professionals
- Integration with assembly, packaging, sterilization, and testing services
As production demand increases, infrastructure remains aligned.
You do not outgrow the system you start in.
Frequently Asked Questions
Do we need our own ISO 13485 certification to use the incubator?
No. Production occurs within LSO’s ISO 13485-certified environment.
Can LSO support FDA registration?
Yes. FDA registration and audit support are part of the incubator framework
Is this only for early-stage companies?
The incubator supports clinical builds, early production, and transition toward scale.
Does the incubator include cleanroom access?
Yes. Certified cleanroom environments are available as part of the program.
Do we need our own ISO 13485 certification to use the incubator?
No. Production occurs within LSO’s ISO 13485-certified environment.
Can LSO support FDA registration?
Yes. FDA registration and audit support are part of the incubator framework
Is this only for early-stage companies?
The incubator supports clinical builds, early production, and transition toward scale.
Does the incubator include cleanroom access?
Yes. Certified cleanroom environments are available as part of the program.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
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