Operations & QA
Operations:
LifeWave is operated by an international network and is led by a management team with extensive experience in electrotherapies, medical technologies and wound care, regulatory affairs and finance. LifeWave - international operations focus on managing the processes of design, production, regulation, and distribution of the company products and services.

 

 
 
Quality Assurance - QA:
LifeWave adheres to the highest standards for the design and manufacture of medical devices. Our quality management system is certified for ISO9001:2008, ISO 13485:2003 and Annex II of MDD 93/42/EEC, and complies with the US Quality System Regulation 21 CFR 820. Our products comply with the requirements of the EU Medical Devices Directive 93/42/EEC.
 
 
Certificates:
 
  • ISO 9001:2008 -- Design, manufacture, marketing and servicing of medical electrical stimulation devices. Registered by AMTAC Certification Services Limited, Milton Keynes, UK
 
  • ISO 13485:2003 – Design, manufacture, marketing and servicing of medical electrical stimulation devices. Registered by AMTAC Certification Services Limited, Milton Keynes, UK.
 
  • CAN/CSA ISO 13485:2003 -- Design, manufacture and servicing of medical electrical stimulation devices for treatment of chronic ulcers. Registered by Intertek Testing Services NA Ltd., a CMDCAS recognized registrar.
 
  • EC Certificate, Directive 93/42/EEC Annex II, full quality assurance system -- LifeWave BST device for the treatment of chronic ulcers. Registered by AMTAC Certification Services Limited, Milton Keynes, UK