Ventura Solutions

12/22/2022

06/29/2022

Looking for a simple overview of the medical device risk management process according to ISO 14971? Check out our latest blog post on risk management! https://ventura-solutions.com/elements-of-medical-device-risk-management-iso-14971/

If you need help with your risk management process or creating/remediating a risk management file, please reach out to us, we love this stuff and are here to help you!

02/07/2022

While the global pandemic caused considerable delays for Medical Device manufacturing due to decreased funding and longer lead times to market, 2021 has moved fast and the industry is back on track.

Where are you with your product development? Need help recovering from a slow down or funding issue?

Let us help you move forward. Ventura-solutions.com

02/04/2022

A new draft of the guidance from the US FDA clarifies what it considers as REMANUFACTURING.

Companies remanufacturing devices are regulated by the agency and they may require new premarket applications.

If you’re finding yourself back in the premarket phase due to remanufacturing your medical device and you need assistance, Ventura can help guide you through the process again.

Contact us so we can help. https://venturasolutionsscheduling.as.me/schedule.php

02/02/2022

Finding top Medical Device talent is hard. Employees want more than a good salary and benefits.

They also want to know the value proposition of your company. Do you have that clearly defined?

We can make sure your company values are clear to our candidates and find you the talent that aligns with those values.

Get in touch to find out more… https://ventura-solutions.com/contact/

01/31/2022

Did you know that issues with CAPAs, complaints, and design controls accounted for 35% of all medical device 483s issued by the FDA in 2020?

Of all the CAPA citations, the most common mistake was a manufacturer’s failure to document or cite procedures.

You must follow a quality CAPA process to be compliant.

Contact Ventura today to discuss any issues you might have with your Quality Management System (QMS) and how we can help resolve your 483 or help you avoid getting one in the future.

Ventura-solutions.com

01/28/2022

Non-dilutive funding from the NIH, is a great way to raise capital without giving up equity.

Ventura Solutions has helped raise millions of dollars in SBIR funding for clients. We can assist you in developing high quality SBIR and STTR grant proposals.

Contact us today about how we can help at https://ventura-solutions.com/contact/

01/26/2022

Human Factors is an important part of today’s medical device product development.

Our team understands the systems you need and how to implement solutions that satisfy IEC 62366 and IEC 60601-1- 6 ed 3.0, to help you with deliverables such as the Human Factors Plan and Report as well as creation of the Use Error Risk Analysis (UERA).

Contact us today about how we can help at https://ventura-solutions.com/contact/

01/24/2022

Are you dealing with a 483 or warning letter? Our team can help when you hit a bump in your process and things get overwhelming.

Schedule a free consultation and we’ll get to work solving the issues and setting up systems to prevent future issues. https://venturasolutionsscheduling.as.me/schedule.php

01/21/2022

We make sure your project remains on schedule and within budget. Our consultants all have deep technical expertise in medical device and pharmaceutical product development.

They’re able to move the project along smoothly with their excellent personal and communication skills -- so you’re never guessing about what’s happening next.

Contact us to find out more at https://ventura-solutions.com/contact/

01/19/2022

Design History File remediation can have a significant impact on your organization's operations.

If not completed properly there will be a significant amount of rework that usually has to occur and this can have a considerable financial impact on your bottom line.

Ensure you get it done right the first time by letting us lead the way. https://ventura-solutions.com/

01/17/2022

Let Ventura Solutions manage your product development project from concept to launch.

Our talented team of engineers will help you to translate your product idea into specific user needs and design input requirements that can be verified and validated in compliance with FDA and international regulatory requirements.

We can produce concepts and prototypes ready for user feedback.

Schedule a free consultation at https://venturasolutionsscheduling.as.me/schedule.php