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Nelson Laboratories announces the expansion of its services with the addition of a dedicated Technical Consulting Services group for medtech companies. Technical Consulting Services encompasses product development, facility and process validation, product performance testing, and regulatory support to help clients deliver medical devices to market that are safe and effective.
"We have some of the world's most distinguished product validation experts here at Nelson Laboratories," says Jeffery Nelson, president and CEO of Nelson Laboratories. "They actively participate in the development of industry standards and guidelines through standards committees that make the industry viable and safe. This depth of experience and industry thought leadership is now readily available to our clients one project at a time."
The Nelson Laboratories Technical Consulting Services team provides a unique perspective with every consult with their approach focusing on the client:
Provides observation and onsite review of client processes, quality management systems, validation files and product development phase gates. This is followed by an assessment and needs discovery process resulting in collaborative development of process changes and tailored solutions for continuous product improvement.
With a depth of expertise, the group provides onsite, client-specific training related to industry best practices, current regulatory and test guidance. This includes webinars for internal client training, development of client-specific training materials, regulatory updates and product-specific case studies.
Product design file review and design phase input with support throughout the product life cycle, including:
•Facility validations (water systems, environmental and process controls).
•Test plans, protocols and written justifications for method selection related to: ?Biocompatibility and material characterization risk assessments (ISO 10993)
- Sterilization validations (EO/Steam/Radiation)
- 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
•Regulatory support for submissions, product changes or rejection notices.
The Technical Consulting group provides help at every phase of the product life cycle and provides impartial advice to maintain the integrity of the services Nelson Laboratories offers.
Source: Nelson Laboratories