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Life Science Outsourcing
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Life Science Outsourcing (LSO) is an FDA-registered, ISO 13485-certified medical device contract manufacturer with facilities in Brea, CA; Somersworth, NH; and Costa Rica — 12 cleanrooms (Class 5–8) across 125,000+ sq ft. We consolidate the regulated late-stage work so device companies ship compliant product faster, with fewer vendors and fewer surprises.

Services:
- Cleanroom assembly & kitting
- Packaging validation (ISO 11607)
- Sterilization validation (ISO 11135 EO, ISO 11137 gamma, ISO 17665 steam)
- Cleaning & decontamination
- Diagnostics consumable manufacturing (J-Pac Medical)

Who we work with:
- Mid-to-large OEMs consolidating vendors
- Startups launching their first FDA-cleared device
- Diagnostics companies scaling from 10K to 10M+ units

Subscribe for cleanroom tours, packaging and sterilization deep dives, and a look inside regulated medical device manufacturing.

→ lso-inc.com to request a quote.

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2:34

Accelerated vs. Real-Time Aging: ASTM F1980 Submission Strategy

Life Science Outsourcing

Shared 4 weeks ago

8 views

2:31

ISO 13485 Certified Is Not QMSR Compliant

Life Science Outsourcing

Shared 1 month ago

3 views

2:35

ISO 17025 Accreditation: What It Means for Your Test Data

Life Science Outsourcing

Shared 1 month ago

11 views

2:00

Sterile Barrier Material Selection: Validation Scope Starts Here

Life Science Outsourcing

Shared 1 month ago

6 views

2:12

ISO 13485 Clause 8.5 CAPA Under QMSR: What Changed

Life Science Outsourcing

Shared 1 month ago

10 views

2:39

ISO 14644 Cleanroom Class Selection for Medical Device Assembly

Life Science Outsourcing

Shared 1 month ago

15 views

3:00

IVD Lot Release Testing: Panel Design & Acceptance Criteria

Life Science Outsourcing

Shared 1 month ago

11 views

2:43

Diagnostics Consumable Manufacturing: Prototype to Scale

Life Science Outsourcing

Shared 1 month ago

6 views

2:41

IVD Consumable Scale-Up: Cleanroom, Validation & QMS Guide

Life Science Outsourcing

Shared 1 month ago

6 views

2:00

QMSR Inspection Readiness: What Auditors Want at the Supplier Boundary

Life Science Outsourcing

Shared 1 month ago

3 views

1:54

ASTM F88 Peel Testing: Setup, Failure Modes, and ISO 11607-1

Life Science Outsourcing

Shared 1 month ago

30 views

2:33

QMSR Audit Prep: What FDA Investigators Expect From Your CM

Life Science Outsourcing

Shared 2 months ago

8 views

2:14

QMSR & ISO 13485:2016: What Changed for OEMs and Their CMs

Life Science Outsourcing

Shared 2 months ago

2 views

2:40

ISO 13485 Clause 7.4: Qualifying a CM Under QMSR

Life Science Outsourcing

Shared 2 months ago

7 views

2:19

QMSR Readiness: Supplier Controls, 483 Trends, ISO 13485

Life Science Outsourcing

Shared 2 months ago

7 views

2:45

ISO 14644 Cleanroom Class for Medical Devices: Decision Guide

Life Science Outsourcing

Shared 2 months ago

52 views

2:41

Microfluidic Cartridge Scale-Up: 4 Decisions That Matter

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Shared 2 months ago

3 views

2:43

Assembly Gates & Medical Device Recalls: Lessons from Impella

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Shared 3 months ago

23 views

2:48

QMSR 2026: What Changed in 21 CFR Part 820

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Shared 3 months ago

45 views

2:23

ISO/IEC 17025 Accredited Packaging Lab: Why Data Provenance Matters

Life Science Outsourcing

Shared 3 months ago

8 views

2:52

ISO 11137-2 Bioburden Testing in Radiation Sterilization

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Shared 3 months ago

48 views

3:19

ISO 13485 Build Gates: Lessons from Abiomed Impella Recalls

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Shared 3 months ago

11 views

2:27

ASTM D4169 Distribution Simulation: Packaging Validation Guide

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Shared 3 months ago

18 views

3:13

Portfolio-Wide Warning Letter: Consolidate to One QMS

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Shared 3 months ago

9 views

2:31

ISO 11607-1 Sterile Barrier Material Selection: 3 Substrates

Life Science Outsourcing

Shared 3 months ago

19 views

2:34

ISO 11607 Packaging Validation: What Each Part Actually Requires

Life Science Outsourcing

Shared 3 months ago

15 views

2:18

Convenience Kit Recalls: Why the OEM Is Always Liable

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Shared 4 months ago

3 views

2:26

Reprocessing Validation: Lessons From the Medline Catheter Recall

Life Science Outsourcing

Shared 4 months ago

8 views

2:19

ISO 13485 Kitting QMS: What the Namic Recall Reveals

Life Science Outsourcing

Shared 4 months ago

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2:17

ISO 14644 Class Selection for IVD Consumables: What Drives It

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Shared 4 months ago

8 views

2:19

ISO 13485 Lot Release Testing for Diagnostic Consumables

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Shared 5 months ago

11 views

3:00

Multi-Site CM Redundancy for Sterile Device OEMs

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Shared 5 months ago

5 views

2:14

ISO 14644 Cleanroom Class Selection for Device Assembly

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Shared 5 months ago

2.1K views

2:30

ASTM D4169 Distribution Simulation for Medical Devices

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Shared 5 months ago

6K views

1:34

FDA QMSR Is Now in Effect — What It Means for OEMs and Manufacturing Partners

Life Science Outsourcing

Shared 5 months ago

17 views