KMS Solutions – Quality shines through Proactiveness

True achievement in quality

is to set a standard
not just following it.

Reach us now

0 +

years of
cumulative experience

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Audits done
globally by team

Multi-millions savings achieved in costs of non-quality (with six sigma and quality improvement projects)

WHO ARE WE

KMS Solutions based out of Netherlands & its alliances (a group of individual freelancers) are your potential partners in providing services for Quality & Regulatory to meet your business needs globally. It’s a group of highly experienced personnel in the field of Global Quality Systems & Regulations in Medical Devices.

In fast changing global regulatory landscape and high demand on quality & safety of Medical products, role of Quality & Regulatory has become key to business success. It is critical to follow the proven design quality principals at early stage of design, so safety and reliability of products is established in proactive manner. This not only creates highly satisfied customers but also prevents significant expenses on cost of non-quality post launch.

Our team has proven skills to guide you managing quality systems and product quality to create maximum satisfaction for customers, keeping the cost of quality as low as possible.

WHAT WE DO

KMS Solutions provides services in following areas..

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

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.

Quality Remediation Activities

Carry out remediation activities - related to US FDA enforcements / Technical File remediation related to CE marking / Regulatory actions from any other competent authority.

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

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.

Complaint Handling Unit

Manage Complaint Handling unit by providing optimized cost services (Hybrid team working from India)

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.

Offshoring activities

Provide offshoring services (from team in India) on Complaint handling, remote support on Quality system, CAPA etc. to take cost advantage.

Cyber Security support

Support development teams to meet cyber security regulation requirements (USFDA, EUMDR etc)

OUR EXPERIENCED TEAM

KMS Solutions based out of Netherlands, Europe are your potential partners in
providing services for Quality & Regulatory for your business.

Rajesh Kathuria

Gert de Vries

S.P. Kalai

Sunil Modhave

Get In Touch

Feel free to reach out. We're here to assist you!

Have a question or just want to say hello? We’d love to hear from you! Drop us a message, and we’ll get back to you as soon as possible.