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Consulting expertise for medical device, diagnostic laboratory, and Software as a Medical Device (SaMD) companies
Our Expertise
![In-Vitro-Fertilization-Shot](https://static.wixstatic.com/media/5f7dd460ab9f4cd6a8a8e534404680d6.jpg/v1/fill/w_980,h_653,al_c,q_85,usm_0.66_1.00_0.01,enc_auto/5f7dd460ab9f4cd6a8a8e534404680d6.jpg)
Experience in Medical Device
IVD ISO13485:2016
FDA Quality System Implementation
![Multimedia](https://static.wixstatic.com/media/71da1b640d84482fafb2676960622207.png/v1/fill/w_980,h_494,al_c,q_90,usm_0.66_1.00_0.01,enc_auto/71da1b640d84482fafb2676960622207.png)
![Image by 2H Media](https://static.wixstatic.com/media/nsplsh_42748c11898e46969b5cbc3277d7b38c~mv2.jpg/v1/fill/w_980,h_551,al_c,q_85,usm_0.66_1.00_0.01,enc_auto/nsplsh_42748c11898e46969b5cbc3277d7b38c~mv2.jpg)
Risk Management per ISO 14971
Audits
![Image by Scott Graham](https://static.wixstatic.com/media/nsplsh_389729e4b79e49aaad5244fadac62807~mv2.jpg/v1/fill/w_980,h_654,al_c,q_85,usm_0.66_1.00_0.01,enc_auto/nsplsh_389729e4b79e49aaad5244fadac62807~mv2.jpg)
![Laptop and Paperwork](https://static.wixstatic.com/media/11062b_a08e2a290da745ce8181d333cfa32ee6~mv2.jpg/v1/fill/w_980,h_636,al_c,q_85,usm_0.66_1.00_0.01,enc_auto/11062b_a08e2a290da745ce8181d333cfa32ee6~mv2.jpg)
Regulatory ComplianceÂ
&
Regulatory Submissions
Research & Development and Process Development for IVD and Research Use Only Products
![Image by Hans Reniers](https://static.wixstatic.com/media/nsplsh_3e5b6eec61e544b8bfb6a4b55ff9c3a6~mv2.jpg/v1/fill/w_980,h_653,al_c,q_85,usm_0.66_1.00_0.01,enc_auto/nsplsh_3e5b6eec61e544b8bfb6a4b55ff9c3a6~mv2.jpg)
![](https://static.wixstatic.com/media/a3c153_aa22866e271a4b9fba587c925c72699c~mv2.jpg/v1/fill/w_980,h_552,al_c,q_85,usm_0.66_1.00_0.01,enc_auto/a3c153_aa22866e271a4b9fba587c925c72699c~mv2.jpg)
Coming soon!
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