Digital Chameleon GmbH aus Basel auf der MEDICA 2020 in Düsseldorf -- COMPAMED Messe
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Digital Chameleon GmbH

Barfüsserplatz 3, 4051 Basel
Schweiz

Ansprechpartner

Senior Project Manager Lillian Marbaise

Telefon
+49 (0) 151 651 70322

E-Mail
lillian.marbaise@digital-chameleon.ch

Head of Brand & Culture Susanne Moll

Telefon
+41 (0) 78 816 23 50

E-Mail
susanne.moll@digital-chameleon.ch

Unser Angebot

Produktkategorien

  • 07  Medizinische Dienstleistungen und Verlagserzeugnisse
  • 07.10  Beratung im Gesundheitswesen

Beratung im Gesundheitswesen

  • 07  Medizinische Dienstleistungen und Verlagserzeugnisse
  • 07.16  Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Firmennews

Datum

Thema

Download

27.08.2020

MDR is coming - Digital Health Quality Revolution® is your solution

You are facing the new Medical Device Regulation with lots of concerns and are already lost in the regulatory maze? 

With our solutions you will be able to achieve MDR Readiness in a lean and effective way. 

WHO WE ARE

Digital Chameleon is an owner-managed strategy advisory firm for Digital Transformation within Healthcare. 

At Digital Chameleon we strive for the Digital Health Quality Revolution® in an unique and agile way.

We navigate our clients through the complex regulatory environment, by providing flexible service packages, that are target- and solution oriented.

If it matters to you, it matters to us !

HOW CAN WE HELP YOU?

If you don't know whether your current processes are MDR compliant

  • OUR SOLUTION : MDR Readiness Check
If you don't know whether your MDR-strategy has Gaps or is sufficient / efficient

  • OUR SOLUTION : MDR Strategy Implementation/ Mentoring & Coaching
If you don't know whether your future product is considered a Medical Device

  • OUR SOLUTION: Support QMS Implementation / Mentoring  & Coaching
If you don't know whether your current product is with the MDR considered MDR- class IIa or higher

  • OUR SOLUTION: Compliance Check
 
DON`T BE SHY, SAY HI 

Interested? Schedule a call with our Sales & Business Operations Manager Sandra Bochnak to find out how you can get a 30 min complimentary exchange with our experts to evaluate your current situation.

Mehr Weniger

Über uns

Firmenporträt

Digital Chameleon can support you and your respective clients with an experienced and competent Quality & Compliance team composed of various experts from the Pharmaceutical, Biotech and Medtech sector (Biotechnologists, Pharmacists, Medical Technologists, IT Technologists and UX / Usability engineers).

We are specialized in digitalization within the Healthcare sector and provide our clients guidance with the introduction and improvement of quality management in an agile environment within a surrounding restricted by numerous regulations. Areas of interest range from LEAN quality management systems, agile computer software validation and qualification, software as a medical device, digital healthcare apps and digital platforms up to quality and audit readiness of state-of-the-art BioTech laboratories and production facilities.

By providing our on point services we are aiming to revolutionize the approach and handling of quality relevant topics within the digital healthcare sector and thereby transform conventional static approaches related to quality management to a more agile and process optimized, mostly paperless working principle following our client´s best interest when it comes to digitalization.

Within our processes we apply profound knowledge and a deep understanding of regulations combined with standards and best practices from the Pharmaceutical, BioTech and MedTech (EU GMP, FDA, MDR), field, pioneering methods in UX /Usability & Requirement engineering and agile software development frameworks (Scrum, Kanban).

The above outlined strategy enables us to provide our clients with a customized quality management focusing on their individual needs and requirements, which facilitates them an easy and efficient navigation to the complex regulatory labyrinth. Our team of experts is willing to take on any type of issue and provide adequate solutions while collaborating closely with our clients and thereby gaining a broad and in depth understanding of the respective challenge to solve. This approach enables us to provide our clients with individual and flexible service packages, that are target- and solution oriented.

We propose solution packages for below fields:

- Quality Management and Regulatory Compliance
- Data Integrity, Privacy and Information Security
- Audit & Assessment Services
- Agile Computer System Validation (CSV) and Software Life Cycle 
  Management
- Digital Health Solutions (SaMD, Digital Health Platform & more)
- Business Analysis, Usability & Requirement Engineering
- Systemic Business Coaching & Change Management

Find out more about our services: https://www.digital-chameleon.ch/


Mehr Weniger

Unternehmensdaten

Anzahl der Beschäftigten

1-19

Gründungsjahr

2019