Smart for today, scalable for tomorrow.

Here at Congenius, we are well prepared to help start-up companies tackle the challenges involved with gaining certification within the highly regulated MedTech industry. We understand that as a company taking your initial steps onto the market, you need to build a solid QMS foundation that will support the enhancement of your core business.

Establishing a reliable QMS system that facilitates compliance with ISO 13485 is a fundamental requirement for achieving certification as a legal manufacturer. Our QMS solution for start-ups is based on robust industry experience and validated approaches, providing you with direction and reassurance as you look to make your mark on the industry.

A QMS system
tailored to your business

QMgeniuS is a QMS system that can be implemented paper-based or electronically via PDF and digital signature. In close collaboration with your company, one of our experienced consultants builds your system, tailoring it as necessary depending on your company’s needs.

The necessary processes and related documents / templates are scoped and then implemented according to your specific requirements. Our smart solution facilitates your certification in a lean way that saves you time and money.

Request a demo

Get in touch

If QMgeniuS sounds like a solution that could help your business, please do get in touch.

You can start the conversation by requesting a demo below. And should you have another Quality-related challenge, take a look at our range of services provided by our Congenius Quality Consultants.

Subscribe to our monthly knowledge update

Stay informed and up to date with the latest industry news delivered direct to your inbox. By subscribing to our monthly newsletter, you will also gain access to our full range of topical content produced by our MedTech industry experts across the Quality, Regulatory, Clinical, eHealth and Operations fields.

Strength indicator

Hint: The password should be at least twelve characters long. To make it stronger, use upper and lower case letters, numbers, and symbols like ! ” ? $ % ^ & ).

By clicking subscribe, you are signing up to receive a monthly newsletter from us containing MedTech news, industry insights and more from Congenius. Subscribing also gives you full access to all topical content on our website. For information on how your data is managed, see our privacy policy.

×

Get in touch

If you have a challenge that you think we could help with, please feel free to get in touch by filling out our contact form or by giving us a call. We look forward to speaking with you!

Congenius AG
Riedstrasse 1
CH-8953 Dietikon

e: [email protected]
t: +41 44 741 04 04

    ×

    Request
    a demo

    Find out more about QMgeniuS by requesting a demo.

    Simply fill out your details and click “Request a demo", then a member of the team will get back to you shortly.

    Alternatively, feel free to give us a call on +41 44 741 04 04 to start the conversation. We look forward to hearing from you!

      ×

      Subscribe to our
      monthly knowledge update

      Stay informed and up to date with the latest industry news delivered direct to your inbox. You can tailor your preferences to prioritise what you'd like to hear about each month; be it MedTech news headlines, fact sheet resources on the latest regulations or longer articles covering timely topics across the wider MedTech industry.

      By clicking subscribe, you are signing up to receive a monthly newsletter from us containing MedTech news, industry insights and more from Congenius. Subscribing also gives you full access to all topical content on our website. For information on how your data is managed, see our privacy policy.