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Design Assurance Support

Design Assurance does Not have to be intimidating.

Having difficulty documenting your user needs, product requirements or just figuring out the best sample size to use for design verification testing? The engineers at AlvaMed have decades of combined design assurance experience across a multitude of product types. Let us guide you by providing informed, risk-based options to help you develop and execute your product development plans.

We take the time to review our clients’ products in depth. A thorough appreciation for how a product works is a key step to providing better design assurance guidance.

Every client has a different tolerance for risk.  We work with each client to assess their risk tolerance and how it aligns with their product development objectives.

We don’t want to be an afterthought. Our design assurance engineers will embed within your product development teams to build relationships and improve efficiency and communication with your stakeholders.

We are focused on applying our practical experience to your design assurance challenges. Our goal is to provide options that balance risk and compliance, allowing clients to select those that best suit their business needs.

AlvaMed’s engineers provide practical solutions to design assurance and risk management challenges.

We were in search of a consulting firm to assist us in tailoring our existing quality management system to meet our specific requirements. That’s when we engaged AlvaMed, and I must say, their performance was truly outstanding.

AlvaMed swiftly grasped the intricacies of our unique needs and hurdles, crafting a bespoke solution that perfectly aligned with our objectives. Their adeptness in implementing the new system, conducting internal audits, and delivering design assurance support was not only impressive but also executed seamlessly, adhering to both our schedule and budget constraints.

I recommend AlvaMed to any medical device company in search of a consulting partner. Their competence and commitment are second to none, and they have undoubtedly been instrumental in our success.

Kelly Ashfield

Materna

We are extremely pleased to share our experience with AlvaMed’s exceptional design assurance support. With AlvaMed’s guidance, we have not only met but exceeded our design assurance goals, resulting in safer and more innovative medical devices. AlvaMed has proven to be a trusted partner in our journey towards design excellence, and we recommend their services to anyone seeking top-tier support.

Joe Dobkin

We were looking for a consulting company to help us with all areas of quality affairs: implementing our first QMS, requirements development, risk management and design verification planning. AlvaMed has a pulse on the size of our company and capabilities and a good understanding of how to support our timelines and resources. AlvaMed right-sized our QMS by considering our internal and outsourced activities. AlvaMed’s experience was invaluable in anticipating needs before they became critical and stepped in as needed with varying levels of support. I would highly recommend AlvaMed to any medical device company.

Michael Pereira

MVS Surgical

Mark’s company AlvaMed is staffed with resources that can bring considerable experience to bear on problems that plague companies developing products in the medical device space. On one large program, we hired AlvaMed to analyze a collection of system specification deliverables to identify any missing, incomplete, or conflicting requirements. The AlvaMed team analyzed hundreds of pages of specifications and returned a detailed report within two weeks. Their quick turnaround and insightful comments allowed the development team to correct several requirement deficiencies and helped keep a critical milestone design review on track. Based on their outstanding combination of experience, responsiveness, and performance I would strongly recommend AlvaMed to medical device manufacturers who need help with product development or risk management issues.

Tim Wech

Program Manager, Boston Scientific

Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.

President

MedTech Client

…you were a one-stop shop – I was able to focus on my business as opposed to managing consultants….

VP Quality Assurance

Teleflex

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

Ready To Schedule A Call?

We look forward to discussing AlvaMed’s services with you.

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Design Assurance Support FAQ's

Any time. We can help clients from the earliest stages of product development through regulatory submissions and beyond. We can be part of the entire design cycle or brought in for a specific issue.

AlvaMed works within each client’s individual spectrum of risk tolerance. For any given issue, we strive to provide choices that span the range of risk, allowing clients to make informed decisions that balance compliance, risk, and business objectives.

We value the relationships our engineers build with their clients. Our objective is to keep the same people on a given project through its completion.

Jon Saltonstall

Vice President of Regulatory and Quality Compliance

Jon spent the bulk of his industry career in startups and appreciates the unique challenges they face trying to successfully navigate the product development pathway. Jon and his team understand that every company has different needs and tolerance for risk.

Ready to learn more about how AlvaMed’s design assurance engineers can help your company achieve its product development objectives?

Schedule time to meet with Jon Saltonstall.  Combined with decades of practical experience, let the design assurance engineers at AlvaMed help you solve your most challenging problems.

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  • Office: 1116 Great Plain Ave, Suite 105 • Needham, MA 02492
  • Mailbox: 935 Great Plain Ave, Suite 166 • Needham, MA 02492
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