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Quality Assurance & Certificates

The BioLegend Inc. Quality Management System (QMS) is certified through our accredited Notified Body TÜV SÜD to ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).

 

ISO 13485:2016 Certification

All products sold by BioLegend Inc. comply with the requirements of ISO 13485:2016. This includes products labelled as Research Use Only (RUO) or GMP Research Use Only (GMP RUO), Analyte Specific Reagents (ASRs), and In Vitro Diagnostics (IVDs) including CE-Marked and registered products in selected countries. Compliance to ISO 13485:2016 ensures all products developed, manufactured and distributed by BioLegend Inc. meet defined requirements for the following QMS processes:

  • QMS document, change and records control, and management review.
  • Product design and development and risk management processes.
  • Production controls, which include infrastructure control, production planning, supplier management, process validation, product inspection, testing, and identification, and preservation and handling.
  • Non-conformances and opportunities for improvement are identified, controlled, and corrected through BioLegend’s non-conformance, Corrective And Preventive Action (CAPA), and internal audit processes.
  • BioLegend continuously monitors customer feedback and resolves customer issues through our Customer Complaint and Feedback and Customer Satisfaction processes.
  • BioLegend ensures each new employee’s skills, education, and experience aligns with the job they will perform. The training process defines specific training requirements for each employee and ensures employees are continuously trained to all new or revised applicable processes and procedures.
  • BioLegend has a highly educated and skilled workforce with approximately 30% holding advanced degrees, including 17% with a doctoral degree (i.e. PhD, MD, DVM).

MDSAP Certification

The MDSAP certification applies to BioLegend’s IVD, ASR, and GMP RUO products produced in our dedicated GMP Suites. To earn MDSAP certification, a company must comply with ISO 13485:2016 and meet country-specific regulatory requirements. BioLegend is currently certified as compliant to the country-specific MDSAP requirements for the United States and Canada.

Certificates of Analysis

A Certificate of Analysis (CoA) contains lot-specific information for a product. To generate the CoA for a product purchased from BioLegend, use our webtool. It only requires your lot number (which begins with B and contains 6 digits).

 

*To retrieve CoAs for kits, please use the entire kit lot number, not the lot number of an individual component. Please contact our technical services group if you encounter any issues.

 

 

 

 

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