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Medqdoc Medical Device eQMS:
Effectively Helping Inossia Achieve Their First Iso13485 Certification

Uppfyller kraven i 21 CFR Part 11

Moving away from a paper-based QMS

Medical device company Inossia wanted to achieve ISO 13485 certification and QSR compliance as part of the process for bringing their new product to market. They identified the need to move away from their paper-based documentation system to help achieve this.

MedQdoc was recommended to them as a medical device eQMS solution which would suit their business and help make the journey to QSR and ISO 13485 certification much quicker and easier.

Achieving ISO 13485 certification and improving processes with an eQMS

When choosing an eQMS, the ability to personalise the system to suit their business was particularly important to Inossia. They also needed a system that would work for their company size but could also be expanded to suit changing requirements and users. MedQdoc’s flexible, intuitive system provided the ideal solution.

MedQdoc quickly revolutionised Inossia’s document control process, bringing significant benefits to their productivity and efficiency, and it now drives the business as their primary software system.

Following the implementation of MedQdoc, ISO 13485 certification was achieved within the expected timeframe, moving Inossia another step closer to commercialising their product.

Download the full case study to discover how MedQdoc helped Inossia achieve a successful ISO 13485 certification with zero non-conformances in just 6 months.

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“We’ve been so pleased with MedQdoc that we’ve already recommended the system to other medical device companies. It immediately brought numerous benefits to our business and ensured we achieved our ISO 13485 certification within our tight time schedule.”

Malin Nilsson, CEO

Five key benefits for Inossia

Inossia found five key benefits of implementing MedQdoc:

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The ready-to-use templates, configured for the medical device industry, have provided significant value to Inossia’s team.

Medical Device eQMS

MedQdoc has made it easier to find and control documentation by moving Inossia away from the old paper-based system.

Medical Device eQMS

The overall time savings for the business have allowed the team to focus on other projects and tasks to drive the company forward.

Medical Device eQMS

By having all documentation easily accessible, communication and processes have been improved across the team, reducing logistical challenges.

Medical Device eQMS

Regulatory compliance has been achieved, with a strong system and processes now in place to support this long term.

What is ISO 13485?

ISO 13485 is an internationally-agreed quality management standard for organisations involved in the design, production, installation and servicing of medical devices. ISO 13485 certification, carried out by an independent certification agency, demonstrates that an organisation’s quality management system has met the requirements of this standard.

Do you need an eQMS to help with your ISO 13485 certification?

Created by our team of medical device and regulatory compliance experts, MedQdoc eQMS is designed to improve your documentation processes and shorten your journey to ISO 13485 certification. Please reach out to us to arrange a no-obligation consultative meeting to find out if MedQdoc could deliver value to your business.

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