Quality & Regulatory Assurance

Niklas Lundqvist, Interim Q&A manager

Boule ensures effective quality and regulatory management

Boule’s commitment to quality and compliance begins with the leadership of our Chief Executive Officer and the Senior Vice President of Quality & Regulatory. They ensure effective quality management through consistent implementation of quality systems across Boule’s operations.
Boule employees and business partners are engaged in quality management activities at all stages of a product’s lifecycle. Our employees embrace the Boule Values and are committed to follow applicable laws and regulations as well as Boule policies and procedures to safeguard that our quality and compliance principles meet customer and stakeholder expectations.

Niklas Lundqvist
Head of Quality & Regulatory Affairs Sweden & RoW

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The quality and regulatory assurance is working to fulfil

  • Boule shall follow all applicable laws, regulations, and requirements.
  • Boule shall comply with our Quality Policy and Quality Management System.
  • Boule shall drive compliance and continuous improvement through audits and inspections.
  • Boule shall ensure that product quality meets customers and stakeholder’s expectations.
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Contact Quality and regulatory assurance

For customer complains please submit a ticket.

Please contact our regulatory department at regulatory@boule.com regarding questions concerning;

  • Registrations
  • Standards
  • Laws and regulations

QA/RA support and cooperation with our Distributors

Boule is working to support our distributors for an effective and compliant registration, service and complaint handling management. We appreciate the effort of distributors to be in compliance with local, global and Boule expectations and to work within a quality system describing applicable demands, and they support us with:

o Following Boule Code of Conduct.
o Marketing of Boule´s products according to Boule approved claims.
o Collecting information from the market regarding safety, performance and customer perception of Boule products and share that information with Boule.
o Implementing needed actions on the market initiated by Boule.
o Registrations, registration requirements and upcoming changes in the relevant market or region.
o Keeping traceability of installed devices – and when required share that with Boule.
o Inform Boule regarding unusual service patterns.
o Communicate updates regarding contact information.
o Communicate Complaints in a timely manner.

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