You need to be familiar with the Finnish reference price system in order to submit price notifications appropriately and on schedule. At worst, forgetting to submit price notification may lead to the medicinal product losing its reimbursability.
The idea of the challenge is to clock up 1,000 kilometres in a year without any help from motors. Many DRA employees took up the challenge, and we were also able to involve our customers.
The process for biological hazard identification and risk assessment is called biological safety evaluation. Often this means an evaluation and testing process based on the ISO 10993 standard.
A new Finnish national legislation has entered into force.
Experiences in successful adaptation of B2B service selling during these exceptional times.
Medicinal products and medical devices alike can be used to diagnose, prevent, treat, and alleviate diseases, or to correct, restore or modify physiological processes.
When a manufacturer applies for conformity assessment from a notified body (NB), the type of devices and technologies subject to conformity assessment activities are to be indicated using designation codes.
Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.
Determining which legislation a product falls under is essential. When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.
One of the most significant new regulatory provisions is related to the increased requirements for internal monitoring by companies, namely the designation of a Person Responsible for Regulatory Compliance (PRRC).
If your company works in the field of medical devices, it is important for you to know that the new Medical Devices Regulation (MDR, EU 2017/745) requires all manufacturers of medical devices to have a quality management system.
Adverse reactions are carefully monitored in clinical trials before a drug enters the market, and after that they remain under constant monitoring throughout the life cycle of the drug. Every report on adverse drug reactions is important for the evaluation of the safety and efficacy of a drug.