KMS Solutions B.V.

KMS Solutions is providing Quality & Regulatory Services primarily for Medical Device and Automotive Industry. While making sure that organization meets all the regulatory requirements, it partners with organization to deploy tools to have proactive approach to prevent quality issues to keep cost of quality at minimum. With having proven global experience of multi-years of it's members , you can rely upon their skills to provide best services. - Management Consulting : Diagnose health of quality function and provide guidance to create program towards high customer satisfaction and low cost of non-quality. Support on running cost of non-quality program. Support on running compliance improvement program like strengthening CAPA process, risk management, post market surveillance / complaint handling processes. - Quality Management System services : Provide services to cater to your needs for Global regulations requirements like USFDA QSR, ISO13485, ANVISA (Brazil), JPAL(Japan) etc. - Product Regulatory approvals: Support on product regulatory approvals like CE / 510(k) / Canada / Japan / China / ANZ / Brazil etc. - EU MDR Transition : Provide services to transition quality systems and products to meet new EU MDR regulation requirements (including Pre-evaluation of Tech files). - Quality Audits : Conduct Mock audits, Support readiness for major audits like USFDA, ISO13485. Take care of your complete audit program Supplier Quality support: Provide support in supplier development / supplier qualification / handling supplier quality issues. - Life Cycle Management: Support Life cycle management of existing products by providing support on handling customer complaints, R&D support, supplier quality etc. - Trainings & Workshops : Provide trainings on QMS Awareness, Internal audit, CAPA, Problem solving tools and techniques, Advance Product Quality Planning (APQP) topics – FMEA, Gage R&R, Statistical Process controls – Cpk & Ppk etc. Contact: rajesh.kathuria@kmssolutions.nl