Leading to competitiveness through innovation in medical devices, biomaterials, and processes.

RESCOLL is accredited ISO 13485 for Research and Development activity on biomaterials, surface treatments, and medical devices.

LRQA ISO 13485Accreditation ISO 13485 [1] for Research and development activity on biomaterials, surface treatments, and medical devices is completely in line with the development strategy of Rescoll. Issued by the UK LRQA, this certification demonstrates our commitment to meet regulatory requirements and the highest quality standards towards our customers in the medical industry. In addition to our certification of compliance with ISO 9001 and ISO 17025 for mechanical testing directly on orthopedic implants [2], RESCOLL is now certified ISO 13485 for the "development of biomaterials, surface treatments, implantable and non-implantable medical devices to be sterilized, according to customer specifications or projects." The maturity level of the quality management system and risk management were identified as strengths by LRQA auditors.

RESCOLL MEDICAL is already involved in developments in the fields of orthopedics, ophthalmology, cardiology, dental, intestines and skin-compatible adhesives. Research and development activities of RESCOLL are diverse and range from literature reviews, formulations (gel, composite, adhesive etc.), surface treatments, to the R&D directly on product like absorbable polymer-based implant, non-absorbable composite and metallic.

For more information please contact Elodie PACARD: rf.ll1537362786ocser1537362786@drac1537362786ap.e1537362786

Download our quality certificates dedicated to biomaterials and medical devices on the following link : http://www.rescoll-medical.com/quality/

 

[1] ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes

[2] http://rescoll.fr/blog/rescoll-accredite-par-le-cofrac-pour-les-essais-mecaniques-sur-implants-orthopediques/