ENABLING DIGITALL™

We can implement a total product life cycle (TPLC) program where medical device cybersecurity risk is evaluated and mitigated in the design, manufacturing, testing, and post-market monitoring activities. 

Does your device meet the expected documentation regarding cybersecurity?

Is your organization ready for GDPR? How about CCPA? Do you have an overarching approach for Data Governance? Can you continually ensure Data Integrity?

These are some of the "hot" areas in Privacy right now. 

The GDPR fines continue to amass; action is necessary. 

Does your existing software validation meet the expectations of FDA, PICS, MHRA, and WHO?

Have a look at the expectations, and we can forge a path forward to meet and exceed them.

It can be done; it requires planning, execution, and vigilance.

 In today’s heightened cyber threat environment, have you:

identified systems, users, data, applications, and entities on the network, including connected devices; identified and managed vulnerabilities in enterprise components.

If not, we can help. 

 The rapid development and constantly changing landscape in our industry, coupled with ongoing changes in compliance regulations, here and abroad, it is of the utmost importance for a company to have an effective strategy and team to achieve such compliance. 

Developing, implementing and maintaining compliance standards requires the visionary leadership and seasoned experience and must go beyond the systems; it is vital in building a collaborative internal culture. 

Let us help instill the “right-the-first-time” mentality and continuous improvement throughout your organization.