Take Your Quality Management System (QMS) to New Heights with easyQ Solutions

At easyQ Solutions, we provide comprehensive Quality Management System (QMS)
solutions designed to enhance compliance, and efficiency.

Working closely with your company, our team of experts develops and implements
QMS solutionssatisfying internal goals as well as regulatory criteria.

Our customized solutions are designed to help you attain continuous
improvement and long-term success

our clients

Trusted by Medtech Leaders Globally

Our Services Include

easyQ Solutions help you develop a strong Quality Management System (QMS) totally aligning with the particular requirements and objectives of your company.

From defining precise quality objectives to building efficient procedures and documentation, we create the foundation for constant performance and continuous development. Our expert team guarantees that your QMS is scalable, regulatory compliant, and capable of supporting sustainable development in a competitive environment.

Our QMS services offers:

We provide a comprehensive solution for defining and applying a Quality Management System (QMS) compliant with ISO 13485, 21 CFR Part 820 , and other global standards. From developing your quality policy to simplifying procedures, our experts will help you at every stage.

Our team of experienced professionals specialises in conducting thorough internal audits to find latent chances for improvement, growth and effectiveness.

In-depth internal audits are conducted to identify gaps and opportunities for improvement. Proven methods are used to analyze your systems and effective Corrective and Preventive Actions (CAPA) are implemented to boost operational efficiency and performance.

  • Our professionals carefully review your existing QMS and identify those points where your system has some gaps and is not working efficiently.
  • We also offer full implementation assistance to guarantee a hassle-free changeover.

  • Our solutions align perfectly with ISO 14971 and IEC 62304, providing you with more than just process definitions.
  • We go further by helping you at each stage with our advisory and also hands-on support throughout the implementation process.

Why Our Experts for your QMS?

QMS Standards

Strong Experience with Global QMS Standards

Hands-on experience in implementing ISO 13485, 21 CFR Part 820, and other global quality system requirements for medical devices.

Audit Expertise

Skilled in Internal and External Audits

Conducted many internal audits and supported companies during external audits by global Notified Bodies and regulators.

Custom QMS Solutions

Customized Solutions, Not Generic Templates

We offer practical, tailored solutions that fit your company and products instead of just providing standard templates.

Certified Team

Qualified and Certified Team

Our team includes certified Lead Auditors for ISO 13485 and ISO 27001, with deep knowledge of quality and regulatory requirements.

Efficient QMS

Simple and Efficient Approach

We believe in a “least burden” mindset keeping your QMS effective and compliant without making things more complicated than necessary.

Regulatory & Industry Expertise

Obrings deep knowledge of global regulatory standards and real-world experience across industries, ensuring your QMS is both compliant and practical.

Built for Continuous Improvement

Our process guarantees that your QMS doesn’t just meet current standards but it is on the same pace with the changes in the company to lift the future of your organization but evolves with your organization to support future growth..

Tailored, Business-Aligned Solutions

Through our solutions, we align your internal organization unique processes and objectives unique processes and objectives driving quality, operational efficiency, and benefits over time.

Integrated with our own QMS Software

We also offer our in-house QMS software designed specifically for medical device companies ensuring that you are in compliance with your requirements

End-to-End Implementation Support

Starting with Gap Analysis and documentation to training of employees and audit readiness we offer full support at every step of the QMS journey.

Streamlined and Scalable

Whether you're a startup or an established enterprise, we support you to be scalable and efficient

testimonials

Hear from our Global Leaders

Strong regulatory support from easyQ Solutions enabled key compliance wins across India and global markets.

DR
Dr Rebecca Funston

Senior Director, Fourth Frontier, India

Thank you for making our ISO 13485 certification and manufacturing license process seamless and successful.

MA
M.R. Abinaya

AVP of Learning & Development, FITTERFLY, India

Trusted advisors and true partners in managing Crely’s Quality Management and Regulatory Affairs.

AS
Arun Sethuraman

Founder & CEO,  Crely Healthcare, Singapore

Thank you for the expert guidance in FDA submissions and QMS

DS
Dr. Swati Shukla

COO, Serigen Mediproducts Pvt Ltd

Grateful  for assisting us in obtaining FDA approval.

RJ
Rasiah Jegathes

President,  EDONORSOFT LLC, USA

Has been an invaluable partner in  ISO 13485 and CE marking journey

SV
Suthirth Vaidya

CEO, Predible Health, India

Thank you for supporting us in our QMS journey. Highly recommended!

JE
Javier Echenique

CEO, GPX Global Systems Inc, USA

Thanks to easyQ Solutions, we achieved ISO 13485 compliance with clarity and precision.

NR
N Ravi

CEO, Biocliq, India

easyQ Solutions was key to building and implementing our QMS successfully.

LE
Laina Emmanuel

CEO, Brainsight, India