True to our claim of service excellence, we strive to identify your needs and wishes and provide the appropriate solutions – even beyond development in the area of Quality Services. Our goal is to provide you with maximum relief throughout the entire development process. For this reason, we are happy to support and advise you in the creation of high-quality and field-tested documents as well as processes.
We present a selection of preferred services here. Do not hesitate to ask us for other support – we will give you a realistic assessment of our abilities.
Our services at glance:
- FMEA-Moderation
- Innovation Workshops
- Quality Consulting
- Clinical Evaluation
- Connectivity and Cybersecurity
You already use FMEA as a tool during the project, but you are dissatisfied with the performance?
We are happy to advise you on the basic structure of an effective FMEA system in your company and support you through the FMEA moderation.
Our invenio moderators are experienced and specially trained developers. They take over the preparation and follow-up of the FMEA sessions and carry out these examinations in your software system (Apis iQ-FMEA or PLATO SCIO-FMEA) – at your site.
Are you looking for innovative solutions and fresh ideas every day? As part of our versatile development projects, we engage almost daily with innovations and creativity techniques to develop novel and individually tailored concepts. Use our strength in joint workshops.
Our services at glance:
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Prepare and plan suitable creative methods
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Moderate the interactive workshops
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Optional participation of experienced invenio developers
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Elaboration of the generated ideas into patentable concepts
Our quality team is responsible for our DIN EN ISO 13485 certified Quality Management System. With the know-how, the team also supports customers in various projects.
We offer you the following portfolio:
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Release-ready preparation of equipment and devices' qualification
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Create rational documents to evaluate facts logically and conclusively
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Gap or Impact Analysis of standards and guidelines
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Advice on creating processes for clinical evaluations a QMS in accordance with DIN EN ISO 13485
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Create and optimize SOPs and forms
If you have a task that requires standard knowledge and the ability to connect and document analytical insights with the topic, then feel free to contact us.
Above all, we see our competencies in such challenges.
We offer you:
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Advice on creating processes for clinical evaluations
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Conduct clinical assessments and review
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Advising on PMS and PMCF
Our services:
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Networking of medical devices (e.g. HIS, PDMS, IoT)
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Cybersecurity assessment of medical devices (including MDS2, GDPR, HIPPA)
Would You like to contact us?
Gladly we are at your disposal for any questions!
