The development and design of medical devices and the use of technologies are strictly regulated in standards and legislation such as the EU Medical Device Regulation (MDR), the Code of Federal Regulations (21 CFR Part 820) or the quality management standard ISO 13485.

Process model for product development

• Bertrandt supports the manufacturers of medical devices in developing their products in compliance with these regulations. The processes prescribed by the regulations were implemented at Bertrandt.
• As a process model in product development, we use – depending on suitability – the V model, the waterfall model or agile project methods. A review takes place after each milestone in order to verify compliance with the requirements.
• The complete product life cycle is accompanied by risk management. We use state-of-the-art development tools and technologies.
• On behalf of the customer, we test individual development phases or the entire product development process, right through to the design history file, and provide technical documentation.
• We apply resources to guarantee quality, safety and effectiveness and at the same time to achieve a shorter time to market.

Our services for product development

• Product design, ergonomics, usability
• Concept development
• Design control
• Material- and production-compliant design
• Dimensional management, tolerance simulation
• FEM calculations
• Computational flow dynamics (CFD)
• Prototype construction, functional samples, prototype tool development and construction

Throughout its history, Bertrandt has been involved in the development of testing methods and has many years of experience in development-supporting and end-of-line test stands. We create individual testing concepts for components and complete medical devices and develop the testing software and hardware required, right through to turnkey and automated test stands.

We combine our expertise in the field of regulatory and legal requirements with the development and execution of tests (test method development, test method validation).

Our testing and test process services

• Combined testing stations and testing equipment
• Condition-based, mechatronic and interconnected testing systems
• Reliability tests, e.g. in climate chambers
• Robot-based testing systems
• Camera-based/optical testing systems
• Test stand construction
• Statistical data evaluation and analysis
• Method development and validation
• Mechanical operational testing.

We have very extensive resources and the expertise of a global group of companies that is active in many sectors. This wide range of services enables us to provide support for even the most complex products throughout their entire life cycle.

We support medical equipment manufacturers with experienced development engineers, with know-how for mechanical design, in hardware and software development and with our own workshops and testing laboratories. This also includes, for example, the development of plastic products in the pharmaceutical area for combination products. Our employees take into account the requirements of the regulated design control processes.

Our experience includes, for example

• CAD tools CATIA, NX, Creo, Solid Edge, Solid Works
• Plastic and metal processing
• Medical technical production
• Installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)
• Creation of written Standard Operating Procedures (SOP)