We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
BioReg offers a wide range of training to instill competence and awareness within your organization.
We can provide online or on-site training sessions (personal or group) as required by your Company on different subjects related to EU Regulations or Quality Management Systems.
Some of the standard trainings include:
- Introduction to the EU MDR / EU IVDR
- Risk Management
- Post–Market Surveillance (PMS), including Vigilance and Post–Market Clinical Follow Up (PMCF)
- PRRC Course: Bringing your PRRC up to speed with the EU Regulations and their responsibilities
- Importer and Distributor Obligations
- Internal Audits
- Supplier Control, including supplier audits
- CAPA Management
- ISO 13485: 2016 masterclass
- Standardization in medicine and pharmacy
- Basics of management in medicine and pharmacy
- Corporate social responsibility (CSR) in medicine and pharmacy
- Pharmaceutical market sizing and related research
- Market Access – basics, significance, and process
- About patent, its design, and patent registration
- What is a trademark
- What are the benefits of IP protections
- How does the patent process work – how to speed it up
- Patent searching
- What steps to avoid to not inadvertently bar yourself from a patent
- Purchasing/selling patent assets
- Infringement & Disputes
After completion of the training, written confirmation will be sent as evidence of your ongoing competence. This notification could be used e.g., as annual ISO 13485 and EU-MDR training for your organization.
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.