Project management

MMC can help you with the overall project management for your product development throughout the development cycle from conceptualization to launch and aftermarket.

We have a guiding principle "do it right the first time" that we strive for. MMC team is has decades of experience and knowledge that can help you guide through all requirements and decisions in the development process so you get the right product, cost efficient as well as decreased "time to market". Our area of expertise is product development in Class I, II and III (EU and USA). Below is a chart of all parts MMC can help you with. 

Research - Concepts and prototypes

We have the resources, means and expertise to help you with conceptualization of your idea. This includes rough concept prototypes to prototypes that can be used to verify function in clinical conditions.

Prototyping is often done with 3D printing or in other materials using other rapid manufacturing methods. We also assemble if needed. These methods enable fast iterations and not so costly prototypes.

Regulatory

A regulatory investigation is performed to establish what overarching laws and regulations that apply and preliminary investigation of standards, including product specific standards, that might apply and starting the risk analysis of the concept. The development requires documentation that is regulatory compliant.

MMC help you start building your technical documentation that is required for all submissions to MPA, Notified Body or FDA.

Design and design control

The design requires compliance to laws, regulations, standards and other requirements. Documentation and specifications of requirements is a fact. Setting user requirements and design/clinical requirements according to the standards and regulations identified with a risk management approach is required.

The development and design must be methodical and follow the guidelines of the regulations/standards with design controls and design reviews. The design history file is initiated with iterations of design and design decisions that will result in the final design of the device. MMC have the means to help in designing the product and modelling in 3D CAD and also build you prototypes and pilot builds with experienced team and state of the art equipment.

It is important to bring out the clinical user's perspective in both performance and in connecting the clinical input to the requirements. MMC can help in translating clinical needs and human factors into technical requirements and solutions together with you and your team

Verification and validation of the product

There are high regulatory demands on the correct execution of design verification and validation and on the risks associated taken into account. MMC can help you in all steps in building your fully compatible plan, protocols and test development.

Production- process development – prototypes - pilot builds

MMC also offers a wide range of prototype development and developing the process to be regulatory compliant.

See tab MANUFACTURING