welcome to

Timo Jäger Consulting

Timo Jäger Consulting in St. Gallen offers consulting services in the areas of quality managment, production and project optimization.

Common challenges

Organizations face the challenge of meeting regulatory requirements while simultaneously making their processes more efficient. The tasks involved are becoming increasingly complex. A possible solution could be found in the digitization of processes.

  • But how is this achieved?
  • Who is capable of doing it?
  • How does an organization implement digital processes?
  • What is required?

We rely on unconventional, out-of-the-box thinking and the ability to see beyond the immediate scope.

services

Quality management

We assist with the implementation and maintenance of a quality management system.

We are also happy to support the digitization of the quality management system and risk management processes.

production- &
process optimization

We support production and process optimizations.

We are also happy to handle the necessary documentation and required training.

traning

Our training programs are up-to-date and tailored to our clients' specific needs.

The training is conducted according to best practice criteria using practical examples.

The participants are actively involved in the training process.

questions

Are you subject to the requirements of ISO 13485 / CFR 820?

We provide support with the implementation, optimization, maintenance, and training related to quality management systems.

Additionally, we assist with the implementation of electronic quality management systems.

Are you subject the requirements of ISO 14971 ?

We provide support with the creation of risk files.

Additionally, we assist with the implementation of electronic risk management systems.

Do you need training for your employees?

Yes, we offer training on the following topics, for example:

  • Good Manufacturing Practice
  • Computer System Validation
  • Equipment and Facility Qualification
  • Product and Process Validation
  • Risk Management
  • 8D, FMEA, Ishikawa, CAPA, Change Management, GDocP
  • Additional topics upon request and availability

Do you want to digitize your company?

We offer support with planning, implementation, and application.

Industry 4.0 and AI are not just buzzwords or clichés for us.

Do you conduct internal or external audits?

We conduct supplier audits, internal audits, and external audits on behalf of clients.

We also prepare for, accompany, and follow up on regulatory audits.

Do your customers need to comply with GMP regulations?

We are happy to assist in handling the communication and explaining the requirements of both customers and authorities.

Projects

Software Implementation

An electronic risk management

system has been implemented here

or documenting the risk file for a

lass IIa medical device.

 

CAPA Management

Due to an audit finding, an

optimization of the CAPA process

was required.

 

 

Digitalization

Required implementation of

electronic signatures in accordance

with the requirements of

CFR 11, CFR 820, EU GMP Guidelines

Annex 11, and Chapter 4.

training

The company manufactures

medical devices, which requires

adherence to GxP criteria.

The employees received training as

GxP Specialists with certification.

contact us

Contact us for a free initial consultation.






location

Timo Jäger Consulting
St. Gallen, Schweiz

about us

Timo Jäger Consulting, based in St. Gallen, offers specialized consulting services focused on quality management, production, and project optimization. Our mission is to help companies maximize the efficiency and quality of their processes. With innovative approaches and deep industry expertise, we provide customized solutions tailored to our clients' needs. We stand for reliability, innovation, and excellent service, making us a preferred partner for companies looking to optimize their business processes.

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