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, during and after successful completion of the preclinical phase. We proudly 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.
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
The certification procedure for medical devices belongs to our day-to-day business. Certification procedures are becoming more and more demanding and face increasing requirements to ensure the suitability of a potential medical device. Nevertheless, innovations ought to be marketable in a commercially acceptable period of time. Although the term does not carry the same meaning in the EU and the USA, we have experience with both the European and the American medical devices. To know these differences is vital as it may influence the regulatory approval and marketing strategy.
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.
The MDR regulates the placement on the medical devices market intended for human use in the EU. It applies, among others, to 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.
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. In case of attempted violations of the regulations and high requirements of the MDR, 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 the technical documentation, and optimise the technical documentation support the complete certification process.