Quality & Regulatory

Quality Management System in accordance with EN ISO 13485

The high quality of our products is obtained through the careful selection of suppliers, continuous validation of processes, and constant inspection backed by control mechanisms.


Our manufacturing areas are clean rooms categorized as Class ISO 8.

Quality Policy

BHL is a company dedicated to the development, production, assembly and distribution of non-active medical devices, sterile and non-sterile, innovative products that are designed to address health technicians, users, and other stakeholders in the business.

We pledge to conduct our business with the most concern and respect for the customer and legal requirements as well as for quality, environment, and health safety at work.

The constant updating of skills, teamwork and support the establishment of partnerships with suppliers, contribute to the innovation and technical product development.

It’s BHL compromise

  • Conduct all activities with the biggest worry and respect for Quality, environment and health and security on job;
  • Comply with the established Regulatory Requirements and standards applicable to Medical Devices;
  • Assure the compliance with the requirements of the quality management system and maintain its effectiveness;
  • Establish partnerships with clients, suppliers and users that contribute for innovation and products development;
  • Update permanently competences, human resources and stimulate the team work;
  • Define and review Quality goals;
  • Promote the communication and BHL notoriety;