CSV | GxP | QA | Audits

Verification of medical devices

provided by internet coaching and internet consulting

Transfer of know-how into your company will be enforced, whereas costs for you will be minimized and it will be explicitly more time for coaching and consulting for your employees.
Thomas W. Hoehle

Dipl.-Ing. Thomas W. Höhle

The engineering company IT-Testing.de consults since 2004 on the areas of software testing, test management and quality assurance, and coaches on the area  of comuterized system validation and the verification of medical devices. For more audit-secureness!
And all if that digitilized.
Here are 3 additional things our costumers compliment us:
  • Maximum service: We identify with the company we are coaching and consultung.
  • Individual costumized strategy: We commit ourselft to the custumer and realize together with the costumer the agreed strategy .
  • Go the extra mile: We are reachable for our custumers at any time and if tasks like software tests can be performed out of odinary business times or on weekends only.

Auf Bewerbungen wird in der Regel innerhalb von 1-2 Werktagen geantwortet.
Our costumers
We consult and coach our costumers online in the industries pharmacy, biotechnology, and medical technology.

Pharmaceutical industry

We coach and consult online pharmaceutical customers regarding CSV and GxP based on GAMP5. We help you to validate your production and business processes as well as the related systems.

Depending on the systems we coach and consult online your employees regarding the validation of applications and the qualification of IT infrastructures. Even though you outsource your IT Infrastructures to an IT provider i.e., cloud services.

We are glad to support your QA team by reviewing documents, maintaining your document management system (DMS) and creating standard operating procedures (SOPs), forms and templates.


Not all biotechnological companies manage the transition from a GLP to a GMP company. We help you with internet coaching and internet consulting to change from a laboratory view to the mode of operation of a company with Good Manufacturing Practice (GMP).

For example to bring together a LIMS (Laboratory Information System) with a MES (Manufacturing Execution System) and an enterprise resource planning (ERP) system to create an integrated network and effective production completely according to GMP requirements.

Medical technology

Customers in the medical technical industry most follow ISO 13485:2016 for quality management systems (QMS) and ISO 14971:2019 for risk management systems (RMS) as well the directives and regulations of the EWG council regarding MDD (Medical Device Directive) or better MDR (Medical Device Regulation) and IVD (In-vitro Diagnostics) with IVDD and IVDR.

We consult and support our customers
via internet regarding those topics and the verification of medical devices and their software. Thereby the IEC 62304 Edition 1.1 and if applicable the IEC 82304:2016 are the basis. 

Moreover, we support you if you consider related processes and systems regarding CSV at your company and the related documention.


We conduct online internal and external audits as well as Mock audits. We prepare your employees for such audits with authorities and notified bodies under realistic conditions.

We also instruct suppliers and service providers and show them which requirements they have to fulfill in a regulated industry.

We comply i.e., to GAMP5 and the requirements of the FDA with MDSAP and QSIT considering the specific standards as well as the regulatories and directives of the EU.

audits and inspections
sustainability by tree planting

Our ecological footprint

 IT-Testing.de is an internet coaching and internet consulting engineering company. We are aware of our particular responsibility for a clean environment. Therefore, at the end of the business year, we donate a part of our profit to projects and organizations to support tree planting.
About Thomas W. Hoehle
I am consultant since 2000 and established 2004 the engineering company IT-Testing.de, There I worked as coach and consultant for software testing, test management, and quality assurance (QA).

Additionally I am specialized as expert for computerized system validation (CSV) since 2011.

I am coaching and consulting freelancers, entrepreneurs and desider of small and mid-sized companies on the areas software testing, test management, QA and CSV as well as audits according to GAMP5, ISO 13485 and ISO 14971.

I consult and coach companies long-ranging and lasting. This shows my consulting periods of one to seven years so far.
How does the application process look like?

1. You make an application to the first interview at no charge.
Within a consulting interview of about 45 minutes we identify which services you, your company and your employees need and which way we shall take and which strategy we shall follow to transfer the know-how to you, to your company and to your employees. 
2. A team member will call you and make a short interview.
We offer our cooperation if we are absolutely sure that we can help you. The internet coaching and internet consulting is suitable for every company but it could be that it does not fit to your current situation. But we will tell you as well when this service will be appropiate to you.
3. We will coordinate an appointd time together.
We are looking for a date for the first interview at no charge. The date shall be prompt so that the information you provide and the problems you name are up-to-date and can be approached as fast as possible.
Our locations

Cathedral of Mainz Germany

Make an application for a first interview at no charge now!
Please note: straight physically it is not possible for us unfortunantely to take care of a handful costumers and to deliver at once strong results.
Our services are asked strongly. To work with us together an application is necessary. During the first interview at no charge we find out together which strategies for our company and your employees are suitable best.
Click the button below to be directed to the application:

computerized system validation qualification QA quality assurance good practices guidelines medical device invitro diagnostics directive test management system development life cycle software testing MOCK audit inspection regulated regulatory authorized notified bodies IT infrastructure application supplier service provider sustainability ecological footprint