Services
We are dedicated to making a difference in the healthcare industry. As an healthcare manufacturer, our primary focus is to support healthcare professionals by providing them with high-quality equipment that enhances people's health and well-being.
How we can help
Our experienced team of professionals is ready to consult on your medical device, product development journey.
Medical device consulting services include, but are not limited to:
Development & Engineering
What experience do you have in medical device development? What investments are needed up-front and what is needed to expand your reach within the market? We know what is needed to develop a medical device, stand out and secure the path to succesful and profitable medical innovation.
R&D and innovation
Helping along the entire R&D value chain from ideation, research, product design. Developing a concept or improving a existing design.
Engineering
Our engineering team can assist with 3D modelling, manufacturing drawings and design for manufacturing.
Validations
We can assist with validations which include but are not limited to :
– Product performance
– Cleaning
– Packaging
– Sterilization
Device & User Testing
Our experience engineers can assist with the setting up of
– Testing protocols
– Conducting user experience studies
– Developing specific testing equipment.
Product Realisation
Our manufacturing solutions reduce your time to market, ensure high-quality output for your product, and create options as you grow your business. With our manufacturing solutions, you can capitalize on our experience to get the job done right and on time. Our QMS, facilities, and services are designed to support both niche complex low volume and mid to high volume manufacturing.
Product Identity
We can assist with the creation of identity for your product which differentiates your product from the rest. Creating a coherent and impactful product presentation.
Manufacturing
We can assist in manufacturing your specific product in plastic and metal through various manufacturing techniques. The techniques are, but are not limit to
– Plastic injection molding
– CNC Machining
– Diamond Coating
Assembly
We can assist in the cleaning, assembly and packing of products in a medical grade clean environment. Producing the necessary work instructions, and quality controls needed for bring a medical device to market.
Labelling
Our state of the art labelling hardware and software insures that traceability and quality adherence gets achieved throughout our manufacturing and assembly process.
Regulatory
An integral part of our Design and Development success comes from the technical and programmatic leadership of our program management team. Our tools and processes ensure a high level of collaboration and accountability with a primary focus on our client’s end goals. Our program management experts provide technical leadership to our delivery teams while leveraging the financial acuity to guide strategic decisions for your products’ success. With our team exclusively focused on medical technology, we empathize with many of the challenges and constraints you face.
ISO13485 implementation
Helping along the entire R&D value chain from ideation, research, product design. Developing a concept or improving a existing design.
Product Technical Documentation
We can assist in preparing technical documentation for your medical device which is in line with ISO13485, MDR & FDA requirements.
Regulatory approvals
Our experienced quality engineers will walk the road of product and QMS certification with you.
