Quality Assurance Services

Quality Assurance Services

Assuring quality and data integrity

Quality Management Systems (QMS) and Quality Assurance (QA) activities are essential for the successful development of Pharma, Biotech, Medical Device and In Vitro Diagnostic products. We offer a range of Quality Assurance services from early development and prototype to post-marketing. Product development requires extensive documentation to ensure reliable results and compliance with local and international regulations. Our team of experts has a wealth of experience covering all GxPs and ISO standards across the life science and health technology sectors from non-clinical and clinical trials, manufacturing, distribution and safety to support you with any challenge.

LINK Medical has Quality Assurance resources in Sweden, Norway, Germany and Denmark covering all aspects of the project from concept to commercialization. Regardless of whether you need to insource one of our QA specialists, to outsource specific tasks or obtain ad hoc QA advice, LINK Medical offers services suited to your unique business needs.

Overview of Quality Assurance services

Quality Management System (QMS):

  • Developing and implementing quality systems in Pharmaceutical, Biotech, and Medical Device and In-Vitro Diagnostic companies.
  • Developing or revising QMS documents, including Standard Operating Procedures (SOPs), quality manuals, and policies.
  • Improving internal processes, reviewing single SOPs or setting up a complete QMS.

Study specific Quality and Compliance assistance:

  • Compliance questions/issues
  • Investigational Products & prototypes
  • Quality checks of study deliverables
  • Oversight

Audit services

  • Regulatory inspection readiness and response
  • Pre-audits and pre-inspections
  • Investigational site audits
  • GCP, GVP GLP, GMP, and GDP compliance
  • ISO 13485 compliance
  • Self-inspections
  • Vendor/supplier audits

Other QA services

  • GxP Training
  • ISO 13485 training
  • Quality Manager outsourcing
  • Specific roles, e.g. Responsible person (RP), RP support, Qualified Person (QP), Person Responsible for Regulatory Compliance (PRRC)

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