Kobridge Consulting assist medical device companies in obtaining CE Marking, implement ISO 13485 or GMP quality systems, submit applications to North America (US and Canada), and more.
The mission of Kobridge Consulting is to assist companies with most international quality and regulatory compliance issues, or if needed to outsource Regulatory Affairs and Quality Assurance (RA/QA).
The expertise of Kobridge Consulting is based on a solid experience in regulatory and quality audits, technical files submission and review as well as process improvement. Kobridge Consulting is also very active in Europe as it is acting as a subcontractor for audits of medical device manufacturers on behalf of European Notified Bodies.
Kobridge Consulting a pour objectif d'aider les fabricants de dispositifs medicaux a obtenir le marquage CE, implementer un systeme qualite conforme a l'ISO 13485 ou aux GMP, soumettre leurs dossiers aux USA ou au Canada.
La mission de Kobridge est d'assister les fabricants dans la plupart de leurs demandes en termes de conformite aux exigences reglementaires, ou si besoin d'externaliser leurs fonctions Qualite et Affaires Reglementaires (RA/QA).
L'expertise de Kobridge Consulting est fondee sur une solide experience des audits qualite et reglementaires, soumission et revue de dossiers techniques et amelioration de processus. Kobridge Consulting est egalement tres actif en Europe puisque realisant pour le compte d'organismes notifies europeens des audits de fabricants de dispositifs medicaux.
코브리지컨설팅은 의료기기회사들의 CE Mark 획득, ISO13485와 GMP 품질시스템 구축 그리고 북미지역(미국과 캐나다) 등에서의 인허가 신청에 관한 컨설팅을 제공하고 있습니다.
코브리지컨설팅의 사명은 국제품질규격 기준에 대한 이해와 아웃소싱 RA/QA 인력을 제공하는 것입니다.
코브리지컨설팅의 전문성은 프로세스 개선 뿐만 아니라 품질규정 심사와 기술문서(Technical File) 신청/검토에 있어서의 풍부한 경험에 있습니다. 당사는 또한 유럽인증기관을 대행하여 유럽 의료기기제조업체에 대해 외주감사(subcontractor) 역할을 하고 있습니다.
