MANUFACTURER LEVEL
EU directives and regulations increasingly impose requirements on manufacturers, importers, distributors and economic operators placing products on the market. Our manufacturer level addresses and consolidates these requirements and supports implementation of effective measures.
Quality & Process Management
Customer satisfaction is the objective of ISO 9001. Other quality management systems focus primarily on product safety (KBA initial assessment, ISO 13485).
We enable your company to fulfil the essential obligations of its quality management systems in a meaningful way.
Sustained product safety and compliance are not a matter of chance.
Obligations of Economic Operators
Compliance requires clear allocation and fulfilment of legal requirements for suppliers, manufacturers, authorized representatives, importers, distributors, operators and customers. Each economic operator must fulfil its own obligations while also providing the information and conditions that other parties need.
We consider these interrelationships already during product and process design.
Risk Assessment & Process Integration
The ISO 12100 risk analysis is systematically integrated into existing purchasing and development processes. Hazards and risks are therefore not considered only on the finished product, but already during product development.
Safety and product quality must be created early and secured through suitable processes.
Market Surveillance & Reactions
Preparation for regulatory enquiries and a structured approach to reporting obligations, product monitoring and field feedback. In the event of deviations or critical incidents, we support assessment, documentation and the required responses.
Internal Production Control
Robust processes and controls ensure series conformity under the applicable EU requirements. This also includes assessing and integrating suppliers and controlling relevant production processes—nationally and internationally.
We provide support worldwide.
Result
There is an awareness that a good product emerges only in conjunction with a good manufacturer. Technical and organizational requirements placed on economic operators must be known and addressed.
Ideally, appropriate product design can eliminate the need to meet certain known requirements imposed on economic operators.