Nelson Laboratories, LLC

Nelson Labs, a Sotera Health company, is the industry-leading global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, protective barrier, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.

Why Choose Nelson Laboratories

We are committed to standards of exceptional quality and rigorous testing, but it is our focus on the bigger picture that really sets us apart. We partner with medical device companies to help them achieve their business goals, such as mitigating risk, being first to market, and succeeding with their customers.

Here are some reasons medical device companies choose Nelson Laboratories to perform their testing:

• Thought leaders and approachable experts. We give you direct access to industry experts who understand your objectives and challenges and can add value every step of the way.
• Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
• Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
• Metric-driven testing processes. We're our own toughest customer, holding ourselves to goals for things that matter most to you, like quality, turn-around time, and testing accuracy.
• Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.

See how we can help you mitigate risk, be first to market, and succeed with your customers.

Medical Device Testing

Getting ready to launch a medical device? Nelson Labs will help you ensure your product meets governmental regulatory agency requirements and validate your product claims. Working with Nelson Labs gives you access to in-depth testing expertise, innovative testing techniques, and world-class facilities and equipment — all designed to help you get your products to market faster and minimize risk. Below are some of the critical tests we offer:

• Biocompatibility & Toxicology Assessments
• Chemical Characterization (Extractables & Leachables)
• Sterilization Validations
• Clinical Reprocessing Validations
• Reusable Medical Device Processing
• Packaging Solutions
• Protective Barriers & Material Performance
• Personal Protective Equipment Reprocessing
• Reusable Medical Device Processing
• Sterility Assurance
• Environmental Monitoring
• Facility & Process Validations

 

Expert Advisory Services

Nelson Labs Expert Advisory Services offers an unparalleled breadth of MedTech and Pharmaceutical experience to help our clients deliver safe and effective products to market. Our Expert Advisory Service encompasses product development, facility and process validation, and product performance testing. Combined with our Regulatory Compliance Associates (RCA) company we can also provide, regulatory and quality compliance support. Learn about what sets our team apart:

• Proven Experience. Experience with successful validation and regulatory approvals across thousands of product types
• Industry Involvement. We remain up to date by actively participating on standards committees and working with industry and regulatory groups to shape the future of MedTech standards (AAMI/ISO/ASTM/PDA)
• Thought Leadership. Each of our foremost expert advisors contributes to industry education through publication, seminars, webinars, and hosted events. By combining their laboratory, regulatory, and manufacturing experience and insights, they give clients a full perspective on critical topics and changes.

If you have a challenging testing question, ask an expert. Our approachable experts are always happy to respond to your questions. They know how to effectively communicate with anyone – regardless of testing background. Get to know our industry-recognized scientists and their areas of expertise.

Regulatory Compliance Associates (RCA)

The Regulatory Compliance Associates® team of life science consultants from FDA-regulated industries has regulated the front lines in regulatory affairs, compliance assurance, quality assurance, remediation strategy and support, and strategic consulting. As your partner, we ensure you receive the highest level of satisfaction on every single project. We know how to get things done with quality results, on time and on budget.

• Regulatory Affairs. From regulatory support to new products to life cycle management to other services like outsourced regulatory affairs, submission, training, and more.
• Quality Assurance. Assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals.
• Compliance Assurance. Guidance for assessments, audits, regulatory agency response, preparation and training, and inspection readiness.
• Remediation. Regulatory action, consulting and manufacturing support to remediate 483 observations, warning letters, untitled letters, and consent decrees.

Education

We believe in the power of education. That’s why we’ve created numerous opportunities for you to fine-tune your skills or learn something new. All designed to help you make important decisions, improve your testing processes, and get better business results.

• Brochures
• On-demand webinars
• Published articles
• Seminars
• Whitepapers

To access our full library of educational offerings, you can also visit our new Sotera Health Academy.