Ventura Solutions is a niche, consulting, staffing, and training firm that is dedicated to meeting and exceeding our clients needs.

Our primary focus areas are design history file and quality system remediation, quality and regulatory support, and product development services for the medical device and pharmaceutical industry.

What makes us different:

Our Values

  • Trust
  • Team Player
  • Open Minded
  • Optimism
  • Honesty

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Our Traits

  • Passion for Saving and Improving Patients Lives with Medical Technology
  • Client Centric
  • Good Humor
  • Team Orientated
  • Flexibility
  • Trust
  • Effective Communicators
  • Self Motivated
  • Strong Work Ethic
  • High Quality Work Outputs
  • Industry expertise

Success Stories

Contract-to-Hire

Identified Needs
Ventura Solutions was contacted to fill a contract to hire Medical Device Quality Engineer position.We met with the client to learn their needs, while listening to the client we realized that they were in need of an individual with 1-2 years of experience to help review and create product development documentation for their organization. The client was struggling with finding the right candidate for over a year. Specifically, they were having trouble finding a well-qualified candidate with 1-2 years of experience and excellent communication skills.

Quantified Gaps
During this time period, there was an extreme shortage of well qualified quality engineering contractors with 1-2 years of experience and this was determined to be the root cause of the client’s pain. The client’s gap was determined to be that they needed a well-rounded individual, with a strong engineering background and training in the medical device industry. As long as the candidate had the required skill set, the requirement for 1-2 of experience was determined not to be a minimum requirement for this specific position.

Determined Solutions
A contract to hire staff augmentation solution was recommended for this assignment. A highly qualified engineer that was finishing up a Ventura Solutions’ Medical Device boot camp training program was recommended for the position. The engineering candidate was a perfect fit for the client’s needs. The candidate was offered a contract position one day after the first interview.

Implemented and Maintained Solutions
After the candidate was placed under contract, Ventura Solutions continued to monitor and follow up on the progress of the contract. As a result of the high-quality performance of the contractor, the client wanted to convert the contractor to a full-time employee 9 months before the agreed upon contract completion date. Ventura Solutions worked diligently with the client to convert the contractor to a full-time employee. The client’s needs were met and exceeded.

Staffing

Identified Needs
Ventura Solutions was contacted for help with a project that involved the product development of a new medical device/pharmaceutical combination product. This project also required significant remediation of the products current design history file. We met with the client and learned that they were on a very tight timeline and that they were resource constrained. The true need was to launch a compliant product into the market and make sure it could pass an audit.

Quantified Gaps
After learning more about the client’s needs it was clear that there was a significant resource gap, Ventura Solutions determined that they needed 2 additional full-time contract resources to meet the project demands.

Determined Solutions
It was determined that the consultants needed to have expertise in design history file remediation and medical device/combination product development. To meet the resource demands as efficiently as possible, Ventura Solutions proposed that the client needed a principal engineer with approximately 10 years of experience and a senior engineer with 1-2 years of experience.

Implemented and Maintained Solutions
Ventura Solutions quickly provided 2 contractors/consultants to be on-site for the duration of the project. Both consultants were interviewed and immediately offered the contract. Once the consultants started working on the project, they quickly exceeded the client’s expectations and were able to take most of the project burden off the client’s organization. Ventura Solutions took on a big part of the project, consistently delivered results, and ensured they were maintained!

Consulting

Identified Needs
Ventura solutions was contacted by a medical device company that needed help starting a new research and development organization. After a few meetings with the client, it was clear that the client wanted to create a world class R&D organization that could launch innovative medical devices that would be safe and effective. The client also wanted to make sure that the organization had robust quality systems in place with efficient design control and risk management processes. Ultimately, they wanted to ensure that as they developed innovative products, they would also be developing FDA and EU compliant design history and technical files.

Quantified Gaps
After learning the needs of the client, Ventura Solutions determined that the gap in the organization was subject matter expertise (SME) in medical device product development, change control, design controls, and risk management. The organization was also lacking some resources in general project management.

Determined Solutions
It was determined that the optimal solution for the client was a flexible hourly based consulting contract with Ventura Solutions. This solution was chosen since it could fill the organizations SME gap as they were building the new R&D team. Ventura Solutions could also create quality system and project documentation as needed.

Implemented and Maintained Solutions
Ventura Solutions became one of the clients top R&D, on demand, outsourced vendor for R&D and on market change control projects. Throughout the course of the engagement, we created a compliant design history file to ensure the launch of a new medical device within 3 months. After the launch of this device we were involved with ensuring the products compliance in the marketplace and helped with expansion into the EU for obtaining CE mark. During the engagement, Ventura Solutions was also able to quickly take over the project management of a top project and lead the launch of three different device configurations within four months. Ventura Solutions also created a new risk management procedure and various quality management system processes. Ventura Solutions served as a turn key service for the clients R&D projects as needed.

What Our Clients have to say

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