Mastering audits successfully

Audit support 
for medical device manufacturers

tecurat GmbH – Support & Coaching


Avoid stress
We know the stress and challenges of an upcoming audit. As certified auditors, we guide you unerringly through all phases of your audit with insider tips and a cool head.


Recognizing deviations
We review your processes, including the associated documentation, for completeness and consistency and detect deviations before your audit and remedy them in compliance with standards.


Strengthening communication
As a coach & mediator, we support healthy and effective communication with the authorities or your suppliers and build bridges when the conversation has ceased or stalled.

Your employees can no longer think clearly on the day of the audit and stumble during the interview?

The development documentation is incomplete but the formerly responsible employees are no longer on site?

The processing of your deviations requires an extension of the deadline, but the request for this is postponed?

Do these topics sound familiar to you?

As certified auditors, we support you in all aspects of audit preparation, implementation or assistance. Take advantage of our experience and arrange a consultation with us.

Master your audits with our expertise

Effective audits through preparation & support

Many manufacturers often require active & experienced support before and after an audit.

Stress situation
Especially before and after a certification audit, there is an extensive task accumulation, which often has to be processed at short notice. Depending on the duration of the persistent pressure to perform, this leads to increased stress for the personnel involved, which often leads to an accumulation of errors. Ultimately, even more work is produced.

Get early support
You as a manufacturer should – to avoid such conditions – fall back on external support in a timely manner.

Communication – the key to reopening closed doors

The importance of objective, expert and cooperative communication is often significantly underestimated.

This is particularly visible at such important milestones such as the certification of your QM system as well as in dealing with your suppliers and employees.

Many problems could be mitigated or remedied as they arise if contact with the counterpart involved – such as the notified body – is sought in good time.
However, this is difficult in the ‘worst case’ scenario, when the future & survival of the company is endangered and the avoidable solutions can only be realized with considerable time and financial expenditure.

In such situations, we support you with our knowledge, gained from many years of customer service as coaches.

In open discussion, pragmatic solutions can also be found for serious deviations.

Our range of services:

The tecurat specialists reliably support you in fulfilling the following task packages:

Internal Audit

We carry out the preparation with you before the emergency and take a close look at your processes and associated documenta-tion.

Supplier audit

We audit your critical suppliers with you and check on site whether the conditions of the quality assurance agreement are actually taken into account.

Authority audit

We accompany you in the upcoming official audits and support you in the preliminary review & compilation of your product documentation.

Efficacy assessment

We examine the implementation of your quality-maintaining, corrective and risk measures and, if necessary, implement efficiency-enhancing solutions.

Discrepancy correction

We develop the time schedule for resolving your audit deviations and, if desired, take over a topic area to be dealt with in a relieving manner.

Employee Training

We train your employees on the require-ments and procedure of an audit and thus help you to complete future audit visits stress-free in the company.

Our range of services:

We are happy to be there for you

How can we help you?
Contact us.

Meet up with us:
In the office or online – or send us an email whenever you want.

We look forward to meeting you!


+49 331 600 87 640