Quality Management System

Helping you write, execute and maintain!

LOK assists its customers in preparing a Quality Management System that conforms to their requirements. We customize our solutions to our customers’ specific needs while ensuring that their Quality Management System complies with regulations.

Our talented consulting team offers a full range of services, leading each time to the implementation of a customized quality assurance system, including the following:

  • Gap analysis (existing system vis-a-vis ISO 13485, FDA Quality Systems Regulations, etc.)
  • Implementation of quality systems
  • Development of SOPs and Quality Manuals
  • Audit Preparations (mock audits)
  • Functioning as a virtual Reg./QA department, including onsite staffing
  • Supplier Qualification and Audit
  • Selection of certification body

LOK also helps customers to meet medical device manufacturers’ internal standards.