Product develop assessment, planning and input requirements, stage gate design process, sourcing components or finished goods are just a few of the ways we can help you with your product development needs.
One of the first steps in medical device product development is to determine if your project will result in a viable product in the healthcare system. We can help with this assessment. Reviewing the product requirements to identify difficult to implement technology that will increase cost, add no customer value and cause a potentially more complex regulatory path.
Planning is key to meeting product development timelines. A critical aspect of planning is having enough time to identity all of the planning and input requirements. By being very disciplined and patient we can help your team to fully and unambiguously state what their deliverables and requirements are (and are not) before starting the design phase of the project. This leads to a smooth-running project with minimal delays.
A key component of product design is to understand the regulatory requirements that will impact your project. Are you designing a medical electrical device? Then IEC 60601-1 3rd edition applies. Do you need to do Usability Studies to be compliant with IEC 62366? We have the experience to help you with these aspects of medical device design.
Will your medical device fall under RoHS (Restriction on Hazardous Substances)? Did you know the compliance date for RoHS 2 (2011/65/EU) is July 22, 2014 for product sold in to the EU? We can help you understand this directive and its impact your products. The substances banned under RoHS are lead (Pb), mercury (Hg), cadmium (Cd), hexavalent chromium (CrVI), polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). Then there is the corresponding WEEE (Waste Electronic and Electrical Equipment) (2002/96/EU) that requires OEMs to manage the collection and recycling of such equipment. A massive undertaking for any company. We can help with this process as well.
Developing contacts worldwide in the medical device sector have given us the ability to source difficult to find products. We have a significant contact database of representatives and manufacturers from around the world. In addition, using on-line sourcing sites has also proven valuable to our clients.
We have the experience to help your team get your medical devices to market in the most expeditious manner. Contact us today to see how we can help you!