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News/Resources 2017-08-08T22:25:36+00:00

News

The Importance of Organizational Risk Management in the Medical Technology World

Risk management is a vital planning step for any organization. Risk management involves identifying and minimizing potential risks for your company. It’s essentially the process of anticipating potential risks a company could face, and taking the necessary steps to reduce the possibility of them occurring. Risk management is important because it protects both your organization

By | August 8th, 2017|Categories: Medical Device Information, Regulators|0 Comments

Kinetic Leap – Part One …

The rear view mirror on Year One of entrepreneurship. Cheers to year one! In the spirit of paying it forward, here are a few reflections on our journey to date: 1. Get comfortable wearing multiple hats (just know when and which one(s) to outsource). 2. Identifying your competitive differentiators can be challenging. Thankfully, our clients

By | May 17th, 2017|Categories: Kinetic Compliance News|0 Comments

The HEAT is on …

Yes, it is summer time for sure – but the HEAT in this instance is the “Health Care Fraud Prevention and Enforcement Action Team” initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services in order to combat health care fraud. Two recent enforcement actions against

By | July 28th, 2016|Categories: Regulators|0 Comments

Update to EU’s Medical Device Clinical Evaluation Guidelines

In June, the European Commission released Revision 4 of MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, found amidst other guidance documents here. The release constitutes a major re-write of the previously issued guidance (found here), increasing the document from 46 to 65 pages of "how-to" conduct the Clinical Evaluation. Though not legally binding

By | July 6th, 2016|Categories: Compliance Updates & Legal Info|Tags: , |0 Comments

Resources

The below companies provide services in the medical device, life science and / or biotechnology sectors and are potential resources for our clients.

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D1ASP0RA specializes in formation of startups in the biotechnology sector. This includes prototyping the concept, developing a financial model, assessing the market, and preparing the story for investors. Our goal is to democratize the path to new discoveries by providing each new idea an opportunity to reach investors.