The Global Regulatory Experts Medical Device Compliance Leaders
MDI Consultants, with over 45 years of expertise, is a premier provider of FDA regulatory compliance consulting, specializing in medical device, pharmaceutical, and food industry sectors. Our comprehensive services support global companies in achieving and maintaining FDA, EU, and Health Canada...
Designing the Future of MedTech From Concept to Commercialization
At HaA Product Development, we specialize in guiding your innovative medical devices from concept to commercialization in the fast-paced, FDA-regulated market. With over 30 years of experience, we partner with clients of all sizes to bring their visions to life, ensuring that each product not only...
Future-Ready Engineering Solutions. Precision. Innovation. Delivered.
SARACA Solutions is an ISO 13485 certified medical device engineering services company delivering innovative, cost-effective solutions with a strong commitment to customer satisfaction, quality, and regulatory compliance. Our multidisciplinary team—comprising quality and regulatory engineers,...
We are a box build contract manufacturer with full supply chain management and control. Our capabilities include automated assembly, clean room, sterilization services, inventory management and logistics. We serve all industries and specialize in highly regulated medical, government and consumer...
Customized Software Solutions
Custom Results Analysis Software: Apartis can help you develop custom results analysis software to precisely control your assay workflow and deliver a fully documented design history file (DHF) to support your regulatory submission (FDA, IVD, 510k, etc.).
We've designed and developed results analysis software for many clients and...
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PLM Product Lifecycle Management
Siemens PLM Software is a world-leading provider of product lifecycle management (PLM) and manufacturing operations management (MOM) software solutions. We help manufacturers realize innovation in their Digital Enterprise by optimizing their processes, from planning and development through...
MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organizations...
Software Design: Our expertise in medical software designing include efficient software development planning, execution and management. We specialize in:
- Medical Software Development [IEC62304:2006]
- Software architecture design
- Software V&V and Compliance Testing
- Field-Programmable Gate Arrays (Electrical...
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Laboratory Equipment Design Medical Product Development
DeviceLab is a contract medical device design and product development firm. We are a full service company for mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services. Expertise includes medical user...
Pentad Design provides expert engineering and design services that can take your idea from concept to finished product for the medical, commercial (including transportation and aircraft), consumer and scientific industries,. Pentad Design utilizes state of the art engineering that will help you...
