QUALITY MANAGEMENT
& REGULATORY COMPLIANCE
 (ISO 13485, FDA 21 CFR part 820)

We provide quality management by establishing, maintaining or enhancing your quality systems according to ISO 13485, FDA 21 CFR part 820 Quality System Regulation and other relevant global QMS requirements.
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Furthermore our solution consists of evaluating Quality processes and applying proven methodologies based on regulations to support you to implement best practices and meet computerized system validation (CSV) needs. 
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The implementation of software as Medical Device is an essential and integrated part of our solution for our Medical Device customers.

AUDIT & ASSESSMENT
(ISO 13485, ISO 9001, FDA, GDP, GMP)

We offer various audit services: from preparing you for an upcoming audit or carrying out an audit on your behalf.  We help you to simplify and to well-organize the workflow and collaboration process to compile audits in order to be compliant with FDA, ISO, TüV Süd/Nord, QM and general audit process regulations.

BUSINESS PROCESS ANALYSIS,
USABILITY & REQUIREMENTS ENGINEERING

We support you through the exercise of defining, documenting, and maintaining requirements within the software development process. In addition, to ensure that you develop a product with good usability, we offer Usability engineering (UE).

ORGANISATIONAL DEVELOPMENT,

CHANGE MANAGEMENT & TEAM COACHING

Your company is on its way into the digital age - one big change process follows the other. Your employees, teams and executives are increasingly in the throes of change. Resilience, self-organization and personal responsibility are necessary skills to succeed here as a company. With the help of systemic business coaching, we help you and your employees to find the right place in the organization and to identify the necessary skills and ultimately make the right decisions.

AGILE COMPUTER SYSTEM VALIDATION (CSV)
& SOFTWARE LIFECYCLE MANAGEMENT
(GAMP5/ IEC 626604/ 82304)

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In the age of digitalization, agile software development meets heterogeneous IT landscape. How do you ensure for instance the stability of the production and at the same time enable faster releases so as not to lose the market connection? Together with you, we develop your tailor-made IT processes, which meet all regulatory CSV requirements as well as the flexibility for the required speed of agile development.

DATA INTEGRITY
 

Within a regulated environment data compliance with ALCOA+ is  indispensable. Within our Data Integrity Assessment Service we evaluate to which degree your data and data governance process complies with the ALCOA+ principle. We support you in the development of effective strategies to manage data integrity risks and stay compliant with the industry standards for data integrity.

DATA PRIVACY 
IT & CYBER SECURITY
(ISO 27001, BSI Grundschutz, Information & IT Security, Data Protection &  Integrity, Secure Communication, Device Integrity, Secure Software Maintenance & Service )

Companies have to constantly monitor, optimize and continuously improve their security system, taking new threats and weak points into account.

We explain how to protect your product from cyber threats and secure your customers' data.

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DIGITAL HEALTH TECH SOLUTIONS
(SAMD, DIGITAL HEALTH PLATFORMS...)
 

Healthcare companies are well-positioned to drive the future of health, but you do not have to undergo this challenging process on your own. Partner instead with us as a specialized regulatory digital health consultancy to meet the changing market needs. If you are in the process of implementing a Software as a Medical Device (SaMD), a Digital Health Platform or need any other Digital Health guidance, the Digital Chameleons are here for you.