Easily Achieve ISO 13485 Certification Through Digitisation

01/03/2023, 09:57 Easily achieve ISO 13485 certification through digitisation
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ISO 13485
Easily
achieve ISO
13485
certification
through
digitisation
EN
In the medical device industry, standards

are becoming increasingly demanding. It
is important for you to digitise your
quality management system, so you can
demonstrate your compliance with the
regulations in one click and obtain ISO
13485 certification easily.
Introduction
Bonjour ! Comment pouvons-
We noticed a common problem among the majority of the medicalnous vous aider ?
actors with whom we spoke:
You have difficulties in meeting the European Union's medical device regulation (MDR)
In order to comply with these regulations, they have the possibility to get ISO 13485 certification
but your quality management system is not up to standard, we explain why, and above all, what is
the best solution to achieve compliance quickly and easily.
https://www.juno.tech/journal/obtenir-simplement-la-certification-iso-13485-grace-a-la-digitalisation?utm_source=organic_social&utm_medium=linkedIn&utm… 1/7
Increasingly demanding standards

The EU MDR standard
The MDR standard was established by the EU to regulate the investigation of the quality and sale
of medical devices.
To summarise simply: this standard was drafted in 2017 to update regulations that had become
obsolete. It came into force in May 2021, and aims to raise the requirements on traceability,
production methods and safety of medical devices.
These standards have a multitude of impacts on your business:
The scope of this regulation is increasing and includes a wider range of medical devices,
an organisation monitors and measures your quality management system,
you have new obligations in terms of risk management, quality, audits, document
management and, more generally, monitoring and traceability,
the demands on your compliance status are greater.
In order to effectively demonstrate your compliance with this standard, you can take your ISO
EN
13485 certification.
ISO 13485 certification

This certification is internationally recognised and sets out the requirements for a quality
management system (QMS) in the medical device sector.
Having this certification allows you to guarantee that your production processes are maintained
and efficient in accordance with your customers' regulations or European market standards.
In order to obtain this certification, you must pass an audit, during which your entire quality
management system is analysed:
the infrastructure is compliant and allows the production of sterile medical devices,
you are aligned with the documentation requirements for traceability and follow-up of
validation decisions,
You have in place a process for after-sales service and for responding to customer
complaints,
You meet the requirements for tracking and tracing production and quality control data,
with a global history of your plant's activity,
the software you use (if any) to manage your QMS is reliable,
you are involved in a continuous improvement process of yourBonjour ! Comment pouvons-
system which allows you to
improve your productivity and performance. nous vous aider ?
And today it's a tough road for you to meet these requirements, both to comply with the MDR
standard, and to pass your ISO 13485 certification.
This is the case because your system is cumbersome, difficult to maintain, impossible to evolve,
perhaps even totally paper-based:
integrating your data is difficult because you need to retrieve all the documents from
multiple sources,
all your controls, production processes and documentation are impossible to consolidate at
the end of production,
you also have no visibility of your plant's activity, so it is impossible for you to design an
effective QMS and continuously improve it,
you lack traceability and history of actions taken.
How digital enables you to comply with

these standards
In order to meet these standards, it is important for you to transform your quality management
system.
However, current software does not fully meet your compliance needs, deploying a QMS, PLM or
MES is a cumbersome and inflexible project to set up and 50% of the time it does not succeed.
EN
Percentage of digitalization projects that fail: 50%.

nous vous aider ?
What you need is agile software such as SaaS, which allows you to regain control over your entire
system. A turnkey solution, which is more adaptable for the end users.
With the digitalisation of the quality management system that Juno brings you:
Your operators can enter their information into an intuitive software program and all your
data is recorded and easily accessible,
data is recorded and easily accessible,
you finally unlock your production data and have real-time visibility on your production
activity,
your documents are systematically consolidated because the system knows which OF they
belong to. No need to retrieve and sort documents manually, your activity monitoring file is
available in 1 click.
you have complete traceability of each procedure, each action, each modification. When
someone applies a cross-check or makes an update to a document or procedure, your
system can identify it and automatically request an electronic signature.
EN
Demonstrate your ISO 13 485 compliance in one click
But that's not all!

Since all your documentation used in production is digitised, you are able to exploit the data
captured for the continuous improvement of your QMS.
This means that you make a quantum leap in your risk management, quality management,
auditing and documentation.
Renewing your ISO 13485 certification every 3 years is a breeze.
Conclusion
nous vous aider ?
Digitalising your quality management system allows you to easily obtain and renew your ISO
13485 certification.
You comply with the MDR regulations and can easily demonstrate that you meet the various
criteria.
Quick implementation software, such as Juno, allows you to set up a QMS in a very short time and
get back to operational excellence.
Discover our white paper:

"How does digitalisation rhyme with
performance?"
EN
Download it here

nous vous aider ?
LET'S TALK ABOUT IT!

LET'S TALK ABOUT IT!
Let's discuss your

operational issues
together
Book a time with our team and let's discuss your
issues. A quick chat is all it takes to see if we can
help you.
Thibaud Godillot - Juno
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01/03/2023, 09:57 Easily achieve ISO 13485 certification through digitisation

Why Juno?  Features Testimonial About us  Book

In the medical device industry, standards

Increasingly demanding standards

ISO 13485 certification

How digital enables you to comply with

Percentage of digitalization projects that fail: 50%.

Demonstrate your ISO 13 485 compliance in one click

But that's not all!

Discover our white paper:

Bonjour ! Comment pouvons-

LET'S TALK ABOUT IT!

Let's discuss your

MON TUE WED THU FRI SAT SUN

Bonjour ! Comment pouvons-

Juno is a SaaS solution Why Juno for your plant? FAQ

Juno 2022 Legal Notice Privacy Policy Terms and conditions

Bonjour ! Comment pouvons-

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