At OTD Packing Service, we have the necessary competencies and an adequate knowledge of regulatory requirements and regulations to consistently ensure quality.
Regardless of the level of the product, it will be handled correctly in regards to regulations. Ranging from the very simple package task to the far more complex, customer-specific total solution.
In cooperation with the customer, we identify the product’s regulatory level, which determines what the product and production require, e.g. in connection with traceability. Regulatory simple packing/assembly tasks are thus also handled simply in terms of documentation. If the product is in a higher class, e.g. within medico, It shall be handled in accordance with the proper regulations.
In this way, we also ensure that the customer only pays for exactly the level that their product requires.
OTD Packing Service is certified according to ISO 9001 2015 and in large parts of our production we work systematically according to ISO 13485. All documentation is managed in our quality management system which also ensures that all registrations, etc, comply with the applicable regulatory requirements. Read more about our ISO certification .
We are MDR (Medico Device Regulative) – compliant according to the stricter requirements that entered into force from May 2021, and all productions are handled by GMP (Good Manufacturing Practice)-trained employees.