Medical DeviceQualified Supplier Directory


HS Design Inc. Company Profile
T: 908/234-2331
F: 908/234-9706

17 Mendham Rd., P.O. Box 613, Gladstone, New Jersey, 07934, United States
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Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows

Markets Supplied: North America, Europe, Worldwide


Innovation and Idea Development HS Design, Inc. (HSD) u...

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Innovation and Idea Development

HS Design, Inc. (HSD) utilizes a systems-based approach with a QMS relevant ISO 13485 design control certification for medical device design and life science instrumentation, including high volume consumer medical devices and disposables. Our expert designers and engineers form a collaborative, cross discipline team allowing us to capture innovation, reduce time to market and maximize the impact of product solutions in multiple areas including Design Research, Graphic User Interface Design (GUI), Industrial Design, Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering, Rapid Prototyping, Documentation Control, Pilot Production and Manufacturing Transfer. A superior network of QMS relevant partners offers a turn-key experience from design though full production, including  design verification and validation, molding, packaging and contract manufacturing.





QMS Relevant Certifications:

  • ISO 13485:2003 Medical Design Certification
  • ISO 9001:2008 Industrial and Consumer Product Certification
  • AAMI Member


  • Research
  • User Interface Design
  • Industrial Design
  • Mechanical Engineering
  • Electrical Engineering
  • Software Engineering
  • Manufacturing Engineering
  • Prototyping
  • Quality Management


  • Product Strategy
  • Intellectual Property
  • Concept Ideation
  • Usability and Ergonomics
  • Mechanical Development
  • Technology Transfer


  • Testing and Validation
  • Project Management
  • Contract Manufacturing
  • Materials & Molding


User-Centered Process

For over four decades, the HS Design value proposition has focused on the humanizing and multi-faceted integration of groundbreaking technology to solve complex problems, while enabling a technology transfer across multiple industries. Our process captures users’ unmet needs, uncovering intellectual property and valuable patent opportunities projects are rapidly channeled through development in a formal design- controlled environment. Design research, Contextual inquiry, user interaction design, formative user requirement generation and summative usability studies are designed to conform to both FDA 21CFR 820.30 and ISO 62366 usability requirements.

Award-Winning Solutions

With over 400 successfully designed products, HS Design is a recognized leader in Medical and Life Science product development. An awardwinning portfolio of surgical tools, medical devices, diagnostic instruments, and consumer health care products showcases the firm’s wide range of clients— from emerging new ventures to Fortune 100 firms. HS Design product design experience also includes packaging design, consumer, commercial, and national security products.

HS Design’s commitment to innovation and user-centered form and function earned the firm two Medical Design Excellence Awards (MDEA) in 2012. View more of their award-winning products here.



HS Design, Inc. wins two 2012 Medical Design Excellence Awards

UBM Canon and MD+DI proudly announced the winning products in the 2012 Medical Design Excellence Awards (MDEA) competition at a presentation ceremony held May 23, 2012 inside the Philadelphia Marriott Downtown hotel. The ceremony was held in conjunction with the MD&M East Event at the adjacent Pennsylvania Convention Center.

HS Design was recognized as a supplier for 2 of the 21 winning products announced out of the 41 finalists. The SnapPath 1000 was the Silver winner in the In Vitro Diagnostics category. The DermScope Imaging system was a Bronze winner in the Radiological and Electromechanical category.

Presented by UBM Canon, and sponsored by Medical Device and Diagnostic Industry magazine, the MDEA program is the MedTech industry’s premier competition for medical device design and innovation. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA-winning products excel in the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.

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HS Design Inc.
T: 908/234-2331
F: 908/234-9706

17 Mendham Rd., P.O. Box 613, Gladstone, New Jersey, 07934, United States
View map


HS Design Inc.


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