Product Development: Professional advice and support – we support your pharmaceutical development
Product development for Medicinal Products
At Mediconomics, you will be guaranteed professional expert advice and support throughout the development of your drug candidate, both during and after successful completion of the preclinical phase.
Full service or partial solutions
We provide these services for clinical trials (phases I-IV), project management, data management, medical writing and pharmacovigilance. Essential steps of pharmaceutical development include design performance and safety, operational economics, risk management and regulatory requirements.
Step by step to the product
We organise these aspects of scientific support in specially developed specifications within our ISO 9001:2015 certified quality management system. You have the option to either outsource the entire project or specific parts of the product development process to us. In each case, we will create a customised strategic plan that fits your product’s requirements and helps to circumnavigate delay causing pitfalls.
Product development for Medical Devices
At mediconomics, the certification procedure for medical devices is part of our day-to-day business. In order to ensure the efficacy and safety of medical devices, certification procedures are becoming increasingly complex. While it is critical that requirements are met, it is also important that innovations become marketable within a commercially acceptable period of time. In addition, procedures vary between the EU and USA. Mediconomics has experience with both European and American medical device certification and can help you navigate the process to obtain regulatory approval and develop a marketing strategy.
MDR Conformity
The Medical Device Regulation (MDR) (EU Regulation 2017/745 on medical devices) came into effect on 26 May 2021 after a postponement due to the COVID19 pandemic. After a transitional period of 4 years, this regulation replaces the previously valid EU medical device directives and the Medical Devices Act. Since regulations, unlike directives, do not require transposition into national law, they apply directly in all EU states.
Compliance with the transitional periods
The MDR regulates the market of medical devices intended for human use in the EU. It provides guidelines for manufacturers, authorised representatives, importers, distributors and other persons mentioned in the MDR. All actors are subject to strict requirements and obligations. For example, manufacturers are obliged to establish, implement and document quality and risk management.
Your protection against high administrative penalties
Medical devices are classified into classes I, IIa, IIb and III in compliance with special classification rules, taking into account their intended use and the associated risks. Classification is carried out in accordance with Annex VIII of the MDR. However, certain obligations and legal consequences are linked to the classification of the products. If the regulations are violated or the high requirements of the MDR are not met, high administrative penalties may be imposed.
For you to remain competitive, Mediconomics and our sister company Medicoforum (certified acc. to DIN EN ISO 13485:2016) take care to determine and confirm correct classification, optimise technical documentation and support with expert advice throughout the entire certification process.
