Medidee er et førende konsulentfirma inden for Regulatoriske forhold, Kliniske forhold og Kvalitetssikring. Medidee ser frem til at invitere jer til disse to gratis online events. Danske virksomheder inden for medicinsk udstyr og IVD-udstyr, får nu mulighed for at høre nærmere om, hvordan man bedst håndterer de regulatoriske udfordringer. Deltagere på eventet “Address the Clinical Data Challenges” vil have førsteret til 1 times gratis regulatorisk check-up, fra vores konsulenter d. 20. Maj.

Medidee, leading consultancy firm in Regulatory Affairs, Clinical Affairs and Quality Assurance is delighted to invite you to these two exclusive free online events. Dedicated to Danish Medical Device & IVD companies, it is the opportunity to share with our experts how to best cope with the Medical Device Regulations expectations. By taking part to the clinical data event you will be allowed priority slots for a 1-hour free regulatory affairs check-up.

10:00 – 10:30 When do you need clinical data for your Medical Device?

The new regulations on Medical Devices increased the need to collect clinical data, Mads will present when we need them
Speaker: Mads Bräuner Madsen, Regulatory expert

10:30 – 11:00 How to get clinical data?

Prospective clinical investigations are only one of the methods to collect clinical data, there are many more, Peter will present how you can collect data in an effective way
Speaker: Peter Sieljacks, Clinical expert

11:00 – 11:30 How to do research in collaboration with a university and ensure it is accepted for regulatory purposes?

Clinical data is the basis of the regulatory acceptance for your device, you have to ensure they will be accepted by your notified body. Kim will present what to take into consideration when assembling data for regulatory purpose.
Speaker: Kim Rochat, Senior Partner