Quality Assurance & Compliance
Product authorization processes and product certification services for household, industrial, laboratory and medical devices, from documentation preparation to laboratory tests
SERVICES
User manual preparation
Whether it is household appliances, electrical equipment, industrial machinery or medical equipment, or other special areas of quality. We prepare user guides and other user documents that are useful and understandable for the target group in such a way that the legal and standard requirements for the descriptions are met.
Services
Elements of our Quality and Approvals service:
User manual preparation
Whether it is household appliances, electrical equipment, industrial machinery or medical equipment, or other special areas of quality. We prepare user guides and other user documents that are useful and understandable for the target group in such a way that the legal and standard requirements for the descriptions are met.
Laboratory testing & EMC
We can support compliance with the standard requirements for individual products with laboratory tests. We help our customers in the evaluation according to the standards and on the way to a positive evaluation, so that they can enter the market with adequate quality.
The tests are carried out with the help of domestic and international accredited laboratories. We place special emphasis on electromagnetic compatibility (EMC) tests for electrical equipment. If the device requires modifications to comply, our engineers will help you with this as well.
CE marking
In order for a product to be sold on the market, after the production of functional prototypes, it must undergo a number of conformity tests.
In the case of European Union distribution, CE certification is required, for which we prepare all supporting documentation, with technical documentation in the case of complex products.
Medical device compliance
We have experience in ISO 13485 quality management for the quality management systems of manufacturers of diagnostic devices.
In addition, we undertake, among other things, the preparation for the MDR (Medical Device Regulation) standard, whether it is about medical aids, measuring devices, or medical devices to be delivered into the body. In all cases, we prepare for the audit process with thorough technical documentation.
We also help throughout the audit, so you can get complex help from us in a legally extremely complex process of quality matters.
Quality management
We provide our partners with the construction and implementation of quality management systems and related consulting for ISO 9001 and ISO 13485 systems.
If they already have some kind of quality management system, we undertake its inspection and internal audit, as well as the planning and implementation of improvement proposals.
Laboratory testing & EMC
We can support compliance with the standard requirements for individual products with laboratory tests. We help our customers in the evaluation according to the standards and on the way to a positive evaluation, so that they can enter the market with adequate quality.
The tests are carried out with the help of domestic and international accredited laboratories. We place special emphasis on electromagnetic compatibility (EMC) tests for electrical equipment. If the device requires modifications to comply, our engineers will help you with this as well.
CE marking
In order for a product to be sold on the market, after the production of functional prototypes, it must undergo a number of conformity tests.
In the case of European Union distribution, CE certification is required, for which we prepare all supporting documentation, with technical documentation in the case of complex products.
Medical device compliance
We have experience in ISO 13485 quality management for the quality management systems of manufacturers of diagnostic devices.
In addition, we undertake, among other things, the preparation for the MDR (Medical Device Regulation) standard, whether it is about medical aids, measuring devices, or medical devices to be delivered into the body. In all cases, we prepare for the audit process with thorough technical documentation.
We also help throughout the audit, so you can get complex help from us in a legally extremely complex process of quality matters.
Quality management
We provide our partners with the construction and implementation of quality management systems and related consulting for ISO 9001 and ISO 13485 systems.
If they already have some kind of quality management system, we undertake its inspection and internal audit, as well as the planning and implementation of improvement proposals.
Why choose us for quality assurance and compliance services?
Engineering expertise in one place
With 150+ years of engineering experience.
Dozens of successful projects
A matter of quality in relation to a diverse product.
Effective communication
During the entire period of joint work.
Quality with guaranteed results
Our work only ends with the end of the audit.
Why trust us when it comes to quality and licensing?
- Structured mental work pays off.
- A joint project is successful when expertise is combined with trust.
Quality is an important area for us, so we do the following to ensure that both are fulfilled as a result of joint work:
- our team has complex knowledge and a technological spectrum
- but we don't stop here, we learn, develop and improve every day
- we will prepare you for everything you will need during the audit
- we work with maximum humility even after many years and dozens of successful authorizations
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years in quality
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pages of documentation
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successful audits
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products certified
Partners
A conscientious team consisting of hardware and software developers, as well as mechanical and engineering competences. We have 150+ years of engineering experience, of which you can be the biggest beneficiary.
In our opinion, it is very worthwhile to do good and well, and structured intellectual work always bears fruit when it comes to quality and licensing tasks.
How do we work?
Quality and licensing from initial ideas to successful implementation
Step 1
First meeting
We assess your goals, requirements, and get to know the product specifications. We recommend only after asking enough questions.
Step 2
Bidding phase
Based on what was discussed, we provide a transparent, easily transparent offer. If there is an agreement, we will enter into a contract and schedule the completion of the work.
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Step 3
Concept creation, process outline
We are moving step by step towards the goal set in the contract. In the meantime, we keep in touch and the documentation is prepared in close cooperation
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Step 4
Fine tuning
We thoroughly review the 90% documentation, making small changes as necessary to ensure the success of quality and licensing.
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Step 5
We accompany you all the way to successful certification
We also assist during the audit, we do not let go of our clients' hands. The successful completion of the work usually does not end the relationship, long-term cooperation is formed with the majority of our clients.
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