Harro Höfliger’s Device Services specialists support you in developing and optimizing your medical devices and products. Your device or the device component of your product is analyzed in terms of feasibility and developed further in collaboration with you and then designed for industrial-scale production. Focus is placed on identifying and minimizing risks. This provides the basis for a rapid and secure scale-up to commercial production. Function and stability testing establishes production readiness. All key aspects are included: In addition to production, this also comprises material, intended purpose, performance, stability and packaging.
- Low-risk scale-up of your device to commercial production
- Support in creating the required product specification
- Support in generating risk analyses with regard to design, product and processes
- Developing test plans based on the risk analyses
- Carrying out functional tests and stability tests
- Generating development documentation in accordance with the applicable standards, for example EN ISO 13485 and 21 CFR Part 820.
We offer individual solutions tailored to your very own personal requirements. Our expert team is happy to get involved in any phase of developing your device and will always be on hand to offer advice.
A successful scale-up phase requires that all project-relevant aspects have been discussed in detail in advance. Our project managers are happy to organize kick-off meetings or project meetings either at your premises or in-house with us.
Additional risk minimization
Proof of Principles (PoPs) / Design of Experiments (DoEs) are carried out for complex processes. This is supported by the statistical software Minitab. Statistical test procedures analyze critical processes and identify the ideal process window.
At what point is it sensible to involve the experts in Device Services?
The sooner the better. With its extensive process and development experience our team can indicate possible critical points in the early stages of a project itself, thus contributing to error prevention. If, for example, the first injection molds have already been created and must be subsequently altered, this will lead to a significant loss of time and money. Even minor details can have a serious impact to some extent. For example, color changes to plastic parts may lead to altered characteristics during contraction, thus changing the fit.
What do you suggest as measures for early error detection?
As a first step it is very important to create a production specification that is as precise as possible. This forms an important foundation of the failure mode and effect analysis (FMEA). In addition, it is key that all risk analyses are carried out as a team with the customer, regardless of whether they relate to the design, product or processes. This is the only way that the technical and pharmaceutical aspects can be equally intensively considered.
What form of documentation do you offer?
We follow the basis of standards EN ISO 13485 and 21 CFR Part 820. We also follow the ICH Q9 guidelines in order to clearly and properly represent the risk management.
These guidelines describe a very good procedure for structuring the development documentation of devices, which is why we also offer a documentation package. We are, of course, also happy to use any customized form of documentation requested by the customer.
Does your team also offer services for already developed products?
Of course! We are pleased to offer a design review. The existing specifications of the product or device are used for the evaluation. The approach to risk assessment and documentation is similar to that of the early phases of development. It is also possible to carry out tolerance analyses on devices that have already been fully developed.