Pace® Services for Medical Devices
From finished products to facilities, we support the medical device industry with comprehensive on and off-site services. Like all manufacturers, medical device manufacturers need to ensure their air, water, and waste is free from contaminants, cleanrooms are certified and monitored, and lab equipment is maintained to operate at peak performance. For combination medical device and drug delivery products, Pace® offers support from early-stage discovery and development to commercialization.
Pace® QA/QC Services for Medical Devices
Our Quality Assurance/Quality Control (QA/QC) services for medical device manufacturers can help ensure your products meet strict regulatory standards and your customers’ expectations for quality, function, and safety.
Pace® materials characterization services help ensure your materials and products meet stringent industry standards and regulatory requirements. By leveraging advanced analytical techniques and state-of-the-art equipment, we provide in-depth analyses of materials used in medical devices, including chemical composition, mechanical properties, and structural integrity. Common materials characterization assessments include:
Testing for pathogens, especially when manufacturing implantable devices, is a critical component of ensuring your devices are safe for patient use. We staff our labs with some of the leading microbiologists in the country so you can be assured the results we deliver are precise, reliable, and adhere to industry standards.
- Bioburden Testing (ISO 11737-1, USP <61>, USP <62>)
- Biological Indicator Testing (USP <55>)
- Sterility Testing (ISO 11737-2, USP <71>)
- Endotoxin Testing (EP 2.6.14, USP <85>)
Are you using ethylene oxide (EO) as a sterilant? If so, you must validate that EO and its degradants - ethylene chlorohydrin (ECH) and ethylene glycol (EG) - have been removed from the product and packaging. Pace® offers EO sterilization validation using ISO 10993-7 guidance to ensure your processes comply with regulatory requirements and ensure quality compliance.
Pace® Support for Medical Device and Drug Combination Products
Pace® provides a wide range of analytical support to establish the performance and safety of your medical device or drug delivery product. We support your innovation by performing the necessary testing and documentation to satisfy regulatory requirements while streamlining workflow. Learn more by exploring our services:
Finished Product Services
Pace® can help accelerate commercialization by ensuring your product arrives safely and performs as intended with go-to-market services tailored to the medical device industry.
Physical Functional Testing
We help establish baselines and verify critical endpoints for your product. Our assessments span everything from the visual appearance of your product to more complex aspects related to compliance.
Stability and Storage Testing
Your product’s safety and efficacy over the designated shelf-life requires testing relevant criteria under the intended storage conditions. Our storage testing services can assess your product’s stability under both accelerated and long-term timelines, applying various available conditions.
Packaging
Make sure your product arrives safely and in compliance with regulations and standards such as ISO 11607 with our product packaging testing. We evaluate the packaging design in terms of strength, integrity, materials, and even labels.
Distribution Testing
Ensure your product can handle whatever your supply chain throws at it with our simulated distribution testing services. We apply methods from both ASTM and ISTA to support a variety of supply chain considerations.
Facilities Management for Medical Device Manufacturing
In the highly regulated medical device industry, any lapse in facility conditions can lead to product recalls, legal repercussions, and damage to a company’s reputation. Pace® Facilities Management solutions for medical device manufacturers can help ensure your operational environment adheres to strict regulatory compliance standards and Good Manufacturing Practices (GMP). Explore our facilities management solutions below.
Regulatory Consulting for Medical Devices
With a deep understanding of global regulatory requirements, Pace® experts can assist you in navigating the intricacies of bringing a device or drug device combination to market and the many compliance requirements that apply throughout the life of that product. Explore some of our solutions below or contact us to start a conversation.
ST108 Compliance Testing
ST108 is a critical standard within the medical device manufacturing industry, ensuring that water used in the processing of medical devices meets stringent quality requirements. This standard, defined by the Association for the Advancement of Medical Instrumentation (AAMI), establishes comprehensive guidelines for testing and maintaining water quality at safe and effective levels for cleaning, disinfecting, and sterilizing medical devices. Pace® provides water quality testing services for each of these areas designed to meet the requirements of ST108 compliance, including microbial content, endotoxin levels, mineral content, and more.
Testing for Waterborne Pathogens
In facilities where water systems are used in the manufacturing process, testing for Legionella and other waterborne pathogens may be warranted. Factors such as sediment, scale, corrosion, and biofilm within water systems can provide a habitat and nutrients for these pathogens to grow. Even construction or remodeling projects can lead to the proliferation of these harmful pathogens.
Environmental Impact Assessments
Like other manufacturers, medical device companies need to keep a close eye on their environmental impact. Pace® has decades of experience helping companies comply with local and federal regulations (RCRA, CERCLA, TSCA, NPDES etc.) and build public trust by demonstrating good environmental stewardship. Explore our various environmental testing services to learn more.
Pace® Building Sciences
“Sick building syndrome” refers to a situation where the occupants of a building experience acute health issues linked directly to the time spent in the building. Despite the cleanliness of most medical device manufacturing facilities, challenges can arise from issues like vapor intrusion, radon, lead and other environmental contaminants. The Pace® Building Sciences team can help you promote a safe, healthy work environment for your employees.
Additional Resources
Case Study: Cross-Training Solutions in an Animal Health Company
Case Study: Overcoming Headcount Restrictions in a Large Company
Info Sheet: Pace® Water Management Planning Services
Info Sheet: ST 108
Info Sheet: Pace® Water Management Planning Services
Info Sheet: Assessing Your Legionella Risk
Webinar: Ensuring Patient Safety: Water Management Strategies in Healthcare