DESIGN AND DEVELOPMENT TO PRODUCT LAUNCH
Do not be fooled – Design and Development is more than just a Design History File!
We know you’ve been told that design and development is all about the ‘Design History File’. This is not true – there’s so much more to it!
Medical technology-specific engineering and production expertise is what’s required, and our team has it.
DESIGN & DEVELOPMENT MENTORSHIP
We provide in-depth, unerring consulting in design planning, design input, design output, design transfer, organisation design reviews, integrating risk management processes and validation/verification. We often examine your current design documentation, noting deficiencies and suggesting solutions to comply with international and local laws. This is great for MedTech start-ups and enterprises expanding into MedTech.
Access-2-Healthcare offers a Design and Development mentorship which goes beyond the compilation of a DHF. A DHF is certainly essential for proving that the devices were developed using the design control process as per FDA requirements, but it is not design and development. We can cover a wide range of medical technology from implants to active medical device, to in-vitro diagnostics, to software as a medical device.
Here is how we can help you:
Creating a clear, structured foundation for your subsequent product design is a critical part of the design and development process.
– Garbage-in, garbage-out – we work with you to explain what exactly is design input
– Systematically help you collate all inter-disciplinary inputs to the design input for your product.
– The end result is clear, structured, and provide a solid foundation for your downstream design.
– Identify relevant standards & regulatory requirements
– WHEN and HOW to apply these standards and regulations exactly
ISO14971-compliant risk management procedures are rare in engineering and product development. We are one of the few ISO-standards drafting committee members that can assist you achieve this integration.
- Establish the risk management file together
- Prepare a file for risk management – USE THE CORRECT RISK ANALYSIS METHOD (because we contributed to writing the standard)
- Make sure your design has a risk management feedback loop in place, and that the risk controls are included into the design.
We provide consulting to help you assess your product for compliance for IEC62366, human factors engineering and perform gap analysis to identify the right resources and facilities to perform product usability testing, particularly to identify and mitigate any associated risks.
We help you identify the relevant standards and regulatory requirements based on these factors early on during prototyping, to streamline the design and development processes – from the technology used, to the assembly of its various parts
What is a technical file good enough for technology licensing? Too much, it becomes restrictive to the licensee. Too little, there’s not enough definition and granularity for licensee to understand. Access-2-Healthcare’s immense experience with various academic, institutional, and hospital research organisation around the world provides you with the ‘JUST RIGHT” Technical File, that has the flexibility for a full Design History File to be completed, or be changed according to the new indications for use and designs.
We aim to keep documentation burden to a minimum.
During the development process, we help your design team examine your design output – technical papers – for substance, quality, and quantity. All necessary regulatory requirements (ISO 13485, FDA CFR Part 21 Section 820) are satisfied, resulting in a safer and better product.
We also analyze documentation line-by-line, conduct unbiased design reviews, and create technical files with the design team.
– With the knowledge from the upstream process, we provide consultation and mentorship to adapt your product design and its related risk mitigation plans for the process and for manufacturing.
– Develop strategic sourcing plan with the company, for budgeting and supplier controls
– Develop production specifications for your control plan
– Design of production line/processes to manufacture, assemble and test
It is our job to help you adjust your product design and its risk mitigation procedures for the manufacturing process and the upstream process.
- Set up budgetary and supplier controls with the organization by developing a strategic sourcing strategy together.
- Specify the parameters for your control plan’s production.
- Design of manufacturing lines and methods for manufacturing and testing of the product
- Plan for process validation, gage R & R and maintenance, validation methods and statistical process control (SPC) planning.
- Small-scale production in order to increase production capacity.
What sets us apart
We hold your hand throughout the entire process. Equipped with real-world engineering and manufacturing knowledge specifically in the medical technology space, our team at Access-2-Healthcare provides in-depth, unerring consultation in design planning, design input and output, design transfer, organisation design reviews, integrating risk management processes, and design validation and verification.
WE GO STRAIGHT TO THE POINT
We can assist you in eliminating superfluous needless information while still giving you with sufficient specs.
Our goal to help you keep documentation burden to an optimum – something very few would know.
If necessary, we can assist in the completion of the complete technical file and in assisting you with commercialization efforts. We use all of these factors to enable us to think creatively and develop novel ways to assist you.