Nelson Laboratories Technical Consulting offers an unparalleled breadth of MedTech experience to help our clients deliver safe and effective products to market. Our Technical Consulting Services encompasses product development, facility and process validation, product performance testing as well as regulatory support.
Each consultant brings a unique perspective based on years of industry, regulatory, and scientific expertise. By participating in industry groups, actively working on the standards committees (AAMI/ISO/ASTM/PDA) and experience working with a broad range of MedTech companies and product types, our consultants bring a breadth of experience to each relationship. Although our lab processes over 50,000 projects each year, our consultants ensure success for our clients one project at a time.
By focusing on what matters most, we help our clients deliver life-saving products with every test through our value-added consulting approach.
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- Improve patient outcomes & minimized risk
- Resolve complex problems
- Get products to market quicker
- Increase product safety and efficacy
What We Do
- Observation and onsite review of client processes, quality management systems, validation files and product development phase gates
- Assessment and needs discovery related to product development to support validation for regulatory compliance and product submissions
- Collaborative development of process changes and tailored solutions for continuous product improvement
- Onsite and client-specific training related to industry best practices, current regulatory and test guidance
- Custom webinars for client training, regulatory updates and product-specific case studies
- Product design file review and design phase input
- Facility validations (water systems, environmental and process controls)
- Regulatory support for submissions, product changes, detentions or rejection notices
- Test plans, protocols and written justifications for method selection related to:
- Biocompatibility, chemical characterization, biological and toxicological risk assessments (ISO 10993)
- Sterilization validations (EO/Steam/Radiation/Hydrogen Peroxide)
- Packaging validations (ISO 11607)
- Reusable and reprocessed devices (AAMI TIR 12/30)
- Product-specific validations and failure investigations
- Development and review of product IFUs/DFUs
- Product or family groupings
- Unique process validations
Why Choose Nelson Technical Consulting Services?Proven Experience
- Experience with successful validation and regulatory approvals across thousands of product types in mutliple MedTech industry segments (medical device, pharmaceutical, tissue biotech).
- We remain up to date by actively participating on the standards committees working with industry and regulatory groups to shape the future of Medtech standards (AAMI/ISO/ASTM/PDA).
- Each of our consultants contributes to industry education through publications, 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.