Legal Manufacturer

Why you need a QM system

Certification and contents

The ISO 13485 standard was published in 2003 to replace existing standards for management systems and design of medical devices. EN 46001, EN 46002 and ISO 13485 have been replaced. The amended standard DIN EN ISO 13485 applies in Germany.

The ISO 13485 is consistent with ISO 9001 in many respects, with one clear difference. While ISO 9001 aims to promote the continuous improvement of products, ISO 13485 is heavily geared towards the implementation of safety aspects. Therefore, it predominantly contains guidelines regarding the marketing and manufacture of medical devices.

ISO 13485 is a harmonized standard with the title "Medical Devices – Quality Management Systems". Medical device manufacturers who are certified according to this standard may (with a few exceptions) place their medical devices on the market without any further "type examination". To this end, the medical devices must be subjected to a conformity assessment procedure in accordance with Annex II of the Medical Devices Directive, which requires an effective quality management system.

Medical device manufacturers may assume that their QM system is effective if they have had it certified under ISO 13485.

 

Certification by notified bodies

Certification involves an initial audit by a notified body (e.g. TÜV in Germany) lasting several days, as well as annual monitoring audits. Notified bodies are state-appointed, independent organizations which audit the implementation of national and European standards.

We can help you construct a lean, ISO 13485-compliant quality management system and clean up your existing QM systems quickly and without any unnecessary costs. Because we must never lose sight of the objective:

to develop and market safe and effective medical devices quickly and without QM overhead.

 

Contents

ISO 13485 was formulated to improve product safety. The document, which arose from the European Medical Devices Directive 93/42/EEC requires that your quality management has clearly defined steps in the manufacture and marketing of medical devices. In addition, 90/385/EEC (for active implants) and 98/79/EEC (for in-vitro diagnosis) were considered.

In order to legally bring out and market a product in the EU, a notified body must carry out the conformity assessment in a procedure which lasts several days. The working environment is monitored in detail to ensure product safety and risk management activities are assessed. In addition, the effectiveness, inspection, traceability and thus documentation and validation of the processes must be ensured in a comprehensible manner.

 

Steps to certification

The TÜV provides four steps for certification. We would love to support you through this process so that you can complete the steps more quickly and cost-effectively. In the first point in particular, we can provide first-class support.

Pre-audit

Preliminary discussion and initial assessment based on a site inspection and review of the
quality management documentation

Initial certification audit - Stage 1

Your QM documentation is checked for conformity with EN ISO 13485. A general audit of your certifiability
is also conducted; this involves an on-site audit. Thorough documentation about the company may also be sufficient here.

Initial certification audit - Stage 2

The application of quality management in your company in practice is audited and assessed.

Certification

If all criteria are fulfilled, you will receive certification of the functionality and compliance with standards of your
quality management system.

If you fall short in one of the audits, the process is repeated. Save yourself a lot of money by setting up your structures
correctly beforehand. We would be glad to help you do so.

 

Inventing, developing and marketing a medical device is something that only successful entrepreneurs can achieve. Most entrepreneurs do not (yet)
have the capacity to also

  • construct a QM system and have it certified;
  • familiarize themselves with thousands of pages of standards and laws;
  • deal with notified bodies and
  • get a product through approval.

 

We believe that people should do what they are best at:

  • You develop products and
  • we take care of the QM system, documentation and approval.

Bringing your product onto the market
quickly and in compliance with the law

With QMSaaS, you save time and money and bring your product onto the market
more quickly and smoothly:

Save time instead of waiting for notified bodies and certification

For most companies, certification is on the critical path: even if a company manages
to develop a product in a short period of time, it takes months to select a notified
body, set up your own QM system, carry out audits and finally get the QM system
certified.

Safety instead of risks (loss of time, penalties) in the event of regulatory problems

If your product, your QM system or your technical documentation does not meet the
regulatory requirements during the audit, approval or, in the worst case, in court,
time-consuming rework is the least-worst outcome. We support you in ensuring that
your product and your documents are legally compliant and that you are spared
delays and even fines in marketing your product.

Orderly development instead of stress and
excessive demands from doing double the work

Developing and marketing products demands so much from many companies that
they do not have the time or energy to write QM manuals and procedure 
instructions, to carry out internal audits and management reviews or to familiarise
themselves with the regulations (thousands of pages of “dry” text). There's no need
for this to be the case, either: QMSaaS takes care of all of this for you.

Saving money instead of being uncertain

You don't have to reinvent the wheel: make use of the Johner Institute's existing QM
service and its experts (auditors, developers, members of standards committees)
who have taken hundreds of products through the approval process. This saves you
time and money. Now that's leverage!
And if, later, you want your independent QM system when your team knows the
processes and regulations: no problem! You can take ownership of all the
documents and continue working.

Get in touch with us so that we can design your lean QM system!

GET IN TOUCH

QMSaaS: How it works (“distributor” scenario)

As a medical device manufacturer, you have to prove that your product meets the legal requirements. To do this, you need technical documentation and, depending on the product, a (certified) QM system. This is set out in law. And it's precisely these points, technical documentation and QM system, that we take care of.

 

Since December 2019, Johner Medical, a subsidiary of the Johner Institute, has
assumed regulatory roles within the European Economic Area as a legal
manufacturer, authorized representative or person responsible for compliance with
regulatory requirements.

Organizational allocation

By skilfully allocating roles, we save you the task of setting up and certifying your own (complete) QM system.

We divide the organizational roles as follows: 

  • You, the IP owner, context expert and distributor: You do what you do best: develop products and sell the product under your name and brand. 
  • We, your regulatory service provider: we make our certified QM system available to you to bring your product into circulation.

 

Organizational allocation

The fastest way for to achieve your goal together with you is to bring your product onto the market in compliance with the law:

 

ActivityWe do these tasks for youYou do these tasks
Create QM handbookX 
Conduct audits and management assessmentX 
Write process and work instructionsX 
Write development plansXX
Provide templates, creating a first draft if necessaryX 
Fill out templates X
Review documentsX 
Compile approval documentsX 

 

Workflow for creating documents

When preparing your technical documentation (also "Design History File" and "Device Master Record"), we proceed as follows:

  1. Template

    • We start creating standard-compliant documents, either using your existing documents or a template or even a first draft from us.
  2. Create / Revise

    • You fill out the template or add to our first suggestion.
  3. Review

    • We review these documents and give you tips for orientation where required.
  4. Compliant document

    • As soon as a document successfully passes the review and thus fulfills the regulatory requirements, we create a version of this compliant document

QMSaaS: How it works (”with developer” scenario)

You want to bring a medical device onto the market that has been developed on your behalf by a non-certified service provider (e.g. agency, programmer, software development company). Johner Medical also provides a range of QM services for these service providers.

  • You, the distributor: You do not purchase your product directly from a service provider, but from a certified OEM (Original Equipment Manufacturer)..
  • We, your OEM: Johner Medical, which owns a QM system fully certified under ISO 13485, assumes the role of OEM. Under its QM wing, the product is developed in compliance with all legal requirements. Johner Medical supplies the product together with all technical documentation.
  • Your developer: Johner Medical outsources all development activities to your developer. In order to maintain compliance with regulatory requirements, your development service provider must work according to the QM specifications of the certified OEM, develop and, if necessary, produce

Get in touch with us so that we can design your lean QM system!

GET IN TOUCH