The reasons are diverse, but mostly they amount to the inability of a start-up company to reach a “critical mass”. In the Medtech space that “critical mass” equates to having an approved product for sale in the US and/or the EU markets as well as a quality, reliable medical device manufacturer behind it.
Consequently, Arazy Group is kick-starting a “Medtech Start-up initiative” that will allow more young companies to reach that “critical mass”. The objective of this initiative is to significantly increase the availability of advanced solutions and medical device technology to physicians and their patients around the world. If you are a start-up company, three to twenty-four months old and managing a budget of less than $500,000 US annually, please complete our application form to see if your company is eligible for any (or all) of the following products, sponsored by LICENSALE.COM:
I) A Regulatory Strategic Report for your product’s US and EU pre market clearance. (Class I/II/III)
II) An Established ISO13485/21 CFR 820 Quality Management System.
III) Your product’s CE Mark:
1) EU – Class I/II Technical File
2) EU – Authorized Representative service
IV) Your product’s US – FDA clearance for a Class I/II product
3) USA – Medical Device Registration | 510(k)
4) The USA – Regulatory Designated Agent
Arazy Group Consultant Inc. has been a leading Medtech regulatory affairs firm since 1995. Operating in hundreds of countries, assisting manufacturers to obtain their product approvals for market access and their companies certified for quality marks. LICENSALE.COM, Arazy Group’s awarded propriety technology, is the only MedTech registration solution that brings any medical device to any market around the world faster and more efficiently than current alternative practices, generating revenues months in advance.