Reduce Risk
Ensure Compliance
Save Cost
Fuel Growth
DELIVER LIFESAVING AND LIFE-CHANGING PRODUCTS WITH MILLSTONE’S TESTING SERVICES
- 25,000-SQUARE-FOOT FACILITY
- 400% INCREASE IN SERVICE CAPACITY
- 100% IN-HOUSE TESTING OPERATIONS
- STATE-OF-THE-ART LABORATORY FACILITIES
- ISO 17025 CERTIFIED LAB
- WORLD-CLASS BI STERILITY SUITE FOR EO STERILIZATION VALIDATIONS
Featured Highlight
How to Validate Sterilization for Products Sterilized by Radiation
Sterile is defined for regulatory reasons using acceptance criteria that are derived from the estimated chance of contamination. For the majority of items, the likelihood of one contaminated product out of a million made products is an acceptable amount of contamination risk. However, depending on the medical equipment or product’s intended purpose, sterility requirements may be more strict or less strict.
Transform complexity into your competitive advantage.
Most medical device manufacturers struggle with the costs and complexities of packaging, testing, and logistics. We’ve developed best-in-class post-manufacturing services that foster quality, compliance, and business success, helping you focus on creating products that make a difference in patients’ lives.
Reduce overhead and overtime
Avoid shipping delays and backorders
Manage lower inventory footprint
Ensure compliance
Simplify inbound supplier coordination
Process voluntary recalls and field returns faster, at lower cost
Unlock the Full Potential of Your Robotic-Assisted Surgery Devices
Streamline operations and ensure quality with our expert guide.
Manufacturers of robotic-assisted surgery devices face complex challenges that can significantly impact their efficiency, economic value, and market position. Overcoming these specific challenges requires an expert partner.
Comprehensive medical manufacturing services with unparalleled quality.
Access expertise that transforms your bottom line. Medical manufacturers worldwide trust us with the capabilities to get to market, maintain position, and manage the product lifecycle.
Packaging
Validation
Quality Critical Inspection
Cleaning and Passivation
ISO Class 7 Cleanrooms
Sterilization Management
Assembly
Testing
Product and Process Monitoring
Environmental Monitoring
Product Testing
Packaging Testing
Testing
Product and Process Monitoring
Environmental Monitoring
Product Testing
Packaging Testing
Logistics
Finished Goods Distribution
Loaner Set Management
Set Building
Reverse Logistics
Bone & Tissue Storage
Cold Chain Distribution
Quality that drives your success and reduces your costs.
Great outcomes start with great products and are backed by excellent processes. Access the expertise, capability, and scale to get your products where they need to be quickly, safely, and cost-effectively—so you can focus on innovation that improves patients’ lives.
Speed time to market
Accelerate ROI and capture market share with packaging expertise that eliminates validation missteps. Deliver your product where it needs to be with superior distribution and inventory management that doesn’t drive up overhead.
Uphold compliance
Ensure products are case-ready with best-in-class clean room and sterilization processes. Avoid costly production delays with quality critical inspection services that detect problems before they impact demand.
Ensure Patient Safety
Protect patient outcomes and reduce your business risk. Access capacity to process the burden of voluntary recalls, re-labeling and overlabeling to bring product under control quickly, safely, and cost-effectively.
Drive Growth
Enable efficiency and increase ROI with labor that flexes and scales with demand, better resource allocation, faster turnarounds, and expertise to manage a smaller inventory footprint.
“We have complete satisfaction in Millstone’s effort and dedication in helping the customer. Doesn’t get much better.”
– Supplier Quality, Large Orthopedic Company
The industry partner of choice.
At Millstone, we believe quality drives patient success. Our mission is to fulfill the obligation you have to the patient with a perfect product — on time, every time.
Our company was founded in 2000 to deliver one service to one customer. Since then, we have built our service offerings around the needs of medical device manufacturers to help them achieve sustainable success at lower cost. Today we offer post manufacturing and aftermarket services to more than 50 customers worldwide, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services with an unwavering focus on quality.
10+
Services
276,000
Square Feet
FDA
Registered
ISO 13485
2016 Registered
