Hazard and risk assessment of particles and fibrous materials.
Product stewardship to control and mitigate potential risks of exposure
DEVICES & DRUGS
Bringing to market of medical devices, biologicals and small molecules (pharma) is a long trajectory of strategical decisions, documentation and adequate testing. Nanoconsult has hands-on experience in these area’s or can connect you to specialists in the field.
The clinical evaluation is a key document in new medical device regulation (rev 4, april 2017). Key is to put your device into comparison to other treatments for the indicated use.
PMCF design and reporting
PMCF is a substantial part of new regulation and device vigilance is the central topic. Clear endpoints and design are forwarded
Ethical board submissions
Ethical boards have their ways of judging dossiers. Nanoconsult brings international hands-on experience and advice
The standard biocomp testing via ISO-10993 is the guideline for CE and FDA. Nevertheless clear differences in handling and communication are important. Nanoconsult can help to prepare, outsource and communicate your tests
We support start-ups and SME. Nanoconsult has hands-on experience of starting up, financing and growing of life tech and medtech companies in various European countries. Through an extensive business network, we can enable the customized support to your business
Accelerating your business by docking into different networks! We enable this process with our own network and committment.
SME matters need attention and sometimes a break or helicopter view. Try it and realize that running to the next is not always helping
Moving to another way of working? We can assist during the process with our experienced coaching partners.
Your team is one of your biggest assetts. Training is a prerequisite and fun. We can organize customized training programs.