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7 Considerations for Choosing a Testing Partner

Expectations for medical device testing are changing, thanks to evolving regulations and standards as well as other factors. Finding the right testing partner is critical for success, so here are a few points to consider.

  • Compliance, Data Integrity, and a Robust Quality Management System

    It may seem obvious, but the compliance, quality, and data integrity provided by your testing partner is critical to the overall success of the product. But how can a sponsor be sure that a laboratory will deliver quality data? 

    Start by conducting a quality audit of your prospective partner and look for a demonstrated record of success. Do they have any 483s or warning letters? Check the FDA Website for red flags. It’s important to do your due diligence before entering into a partnership.

    Image courtesy of Eurofins Medical Device Testing
  • Comprehensive Global Capabilities and Local Expertise

    Managing approved vendor lists, Master Service Agreements, and NDAs is not only exhausting, but also costly for a corporation. When selecting a testing partner, look for organizations that have deep expertise with a broad test offering. This combination helps maximize your needs across the entire development cycle.

    Whether you’re a regional or multinational company, selecting a testing partner with industry-leading capabilities and a truly global presence will provide the services and geographical reach with the local expertise you’ll need. 

    Image courtesy of Eurofins Medical Device Testing
  • Experience

    When selecting a testing partner, understand that experience comes in many different varieties. Testing experience, therapeutic experience, and regulatory experience are just some of the critical factors that determine the overall success of your product development. 

    Look for an organization that brings all of these essential elements to the table. Many times smaller partners with targeted experience may provide value for one area, but often times, larger testing organizations that leverage a vast network of people and experience provide the most value.     

    Image courtesy of Eurofins Medical Device Testing
  • All Regulatory Expectations Met

    Don’t underestimate the power of a partner that can think strategically. Regulatory guidelines and standards are changing faster than ever. When choosing your testing partner, look for an organization that understands not all projects are designed to just “check the boxes.”

    While some progress has been made in the standardization of global testing requirements, understanding the intricacies of global and local markets is critical. Look for a testing partner that is connected globally to the regulatory bodies and demonstrates the ability to think outside the box. 

    Image courtesy of Eurofins Medical Device Testing
  • A Designated Single Point of Contact

    We’ve all been in this situation—up against a wall or desperate for answers/results and all you get are voicemails and handoffs. Sometimes testing partners offer the benefit of vast experience and an abundant list of clients, but this can sometimes come at the cost of infrequent communication, creating the feeling that you’re a small fish in a large bowl for that company. 

    Select a testing partner with a proven communication system that includes an assigned project manager who is dedicated and committed to your projects and your needs. There will always be some challenges along the course of product commercialization, but selecting a partner that understands your needs and that you can communicate with effectively will allow you to quickly overcome those obstacles. 

    Image courtesy of Eurofins Medical Device Testing
  • Timely Results at a Competitive Price 

    Is it possible to deliver industry-leading turnaround times at competitive prices? In short, absolutely. Expertise, quality, and locations are critical, but budgets and maybe most importantly turnaround times could make the difference in the success of your product commercialization. 

    Look for a partner that can save you time and money during the development process.  Identify a testing partner that strategically invests in its facilities, processes, and electronic systems. 

    Image courtesy of Eurofins Medical Device Testing
  • Beware of Overinflated Promises and Scope Creep

    Watch out for laboratories that over- or under-sell services only to change the scope of testing after receiving your project, costing you time and money. Do your research, request quotes from multiple vendors, ask questions about variations, and utilize regulatory agencies for pre-submission requirements.

    Image courtesy of Eurofins Medical Device Testing
Andrew Gottfried is the Director, North American Sales, for Eurofins Medical Device Testing

Andrew Gottfried

 

Andrew Gottfried is the Director, North American Sales, for Eurofins Medical Device Testing. He holds a Bachelor of Science degree in Marketing and Advertising from Ball State University and a Master of Business Administration degree from Eastern Michigan University. With more than 20 years of experience, his focus on medical device testing and development has focused on toxicology, risk assessment, analytical chemistry, and biocompatibility.

Prior to joining Eurofins Medical Device Testing, Gottfried held multiple positions with increasing responsibilities within the medical device industry as well as two Fortune 500 manufacturing companies and a start-up software company. His associations include the Society of Toxicology, the Michigan Regional Chapter of the Society of Toxicology, the Medical Device Specialty Section of the Society of Toxicology, and the American College of Toxicology. He has served as the President of the Michigan Regional Chapter of the Society of Toxicology, as a member of an Institutional Animal Care and Use Committee (IACUC), and as a member of the CAAT Advisory Board at John’s Hopkins University.

  
With  more than 20 laboratories in North America, Europe, and Asia Pacific, Eurofins Medical Device Testing offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service and the most advanced technologies for analytical chemical, microbiological, biocompatibility, electrical, mechanical, and package testing needs. With a dedicated project manager to serve as the point of contact across the global networks for a project's full range of testing, Eurofins Medical Device Testing meets project needs from virtually anywhere in the world.

Eurofins Medical Device Testing has responded to the growing demand for testing with a new 168,000-sq-ft facility at the Lancaster, PA campus and a fully customized and validated LIMS system and access to live project information 24 hours per day, 7 days per week with our online data access tool, LabAccess.com.

Eurofins Medical Device Testing will be exhibiting at MD&M Minneapolis in Booth #1840.

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