Bringing a complete portfolio of design, prototyping, simulation, and testing under one single roof, our fully integrated development cycle enables us to offer an optimized design control package in line with FDA guidance for medical device design and development for components and assemblies.
Our design and development engineers take your idea from concept to completion, incorporating the most sophisticated techniques and technologies in the medical device industry. We lead reviews, hazard identification, and risk analysis diligently throughout our documented process.
Medical Product Design &
Solidify your Medical Device Design, Development and Manufacturing from the start.
Design For Manufacturing focus, Supply Chain focus, Regulatory Support, Volume Scale Preparedness
One of SEISA’s best advantages lies in our vertical integration strategy that encompasses concept to Commercial approval, scale production and maintenance to manage for Supply Chain risk. Experience with a wide variety of medical devices. Our team has experience in both medical device design and manufacturing. This allows SEISA to “marry” design and manufacturing for better results.
Aside from Non-disclosure agreements, SEISA maintains strong systems to protect customer data. Access only for the design department with separate server system.
- Dedicated equipment for fast extrusions and injection molding. Fixtures and assembly equipment ready for iterations.
- Team of program managers and engineers are ready to help with your medical device design and iteration needs.
- Dedicated Bench Testing Equipment
- SEISA’s design and development lab is capable of performing most bench tests as required by MDR, ISO 13485 and guidance by FDA for 510k approval.
Medical Device Design and Development Case Study
- One challenge seen in our industry is companies outsourcing the full development of their medical devices. Likewise, start-ups often piece together a risky piecemeal supply chain from design start.
- Smaller companies are unable to take on FDA or MDR registration for complicated and challenging supply chain.
- Companies may choose critical medical device components from companies that may not have the financial or operational feasibility to supply components competitively in the long term. This can hurt a company’s ability to procure in the future or affect their valuation when selling.
- SEISA helps customers streamline their supply chain from the start.
- Select from an array of in-house services
- Design your supply chain from the start with SEISA’s team of experienced and qualified engineers.
- Streamlining Design For Manufacturing and Supply Chain from the start avoids short- and long-term issues.
Design and Development FAQs
What is the Medical Device Development Process?
The medical device development process is a set of practices and procedures required which have specific phases to be followed to ensure good quality practices so that the medical device design is effective and safe for its intended use.
As a result, the medical device development process covers the entire life cycle of a medical device, from the concept to its commercialization.
How are medical devices designed?
For the medical device design there are some general steps in the medical device product development life cycle that are follow across the board. These steps can include the concept or initiation, the formulation, design, and development, including the design verification and validation, final validation, product launch and postlaunch assessment.
What are important design considerations for medical devices?
The important design considerations for a medical device include the performance of the device, safety features or characteristics, sterilization, materials selected and their biocompatibility, usability engineering or human factors, compatibility with other medical devices, labeling, packaging, shelf-life, and regulatory requirements.
What should you look for when selecting a medical device design company?
You should look for a medical device design company that has a Quality Management System where the ability to provide medical device design and related services that consistently meet customer and applicable regulatory requirements is demonstrated. As well as the capability of creating the concept, product design, prototyping, testing for verification and validation, manufacturing, and experience to create the commercial submission to a regulatory body, such as the Food and Drug Administration (FDA) in the United States.