Medical devices of the highest quality
Medical quality standards
Whether it’s the cleanliness of the facilities, staff training or the implementation of processes, quality comes down to suitability for the purpose, and the purpose of a medical product is to support health. This is precisely where our thinking begins, ensuring we adhere to the standards you set and meet legal requirements as a minimum. This is also reflected in our certification in accordance with DIN ISO 13485, which we have successfully maintained since 2010, having been repeatedly recertified with distinction for over a decade.
Validation
Risks to health? No thanks!
Minimising the risk of product defects through manufacturing, testing, or logistics requires considerable effort. Through the structured validation of each step and by creating the required transparency, we work with our partners to reduce the risk to an absolute minimum.
VALIDATION CREATES CONFIDENCE
Although generally considered to be of the highest importance, validation nevertheless does not always get the attention it deserves.
At Scholz, we don’t see validation as a necessary evil, but rather as an essential cornerstone for medical devices of the highest quality. Therefore, right from the quotation stage we set out the specific needs and requirements for a validation with our customers.
CONFIDENCE CREATES CERTAINTY
We can offer you various modules for this, such as statistical quality control (SPC), statistical design of experiments (DoE) or validation based on a risk-based approach using DQ/IQ/OQ/PQ according to our customers' specifications. - All accompanied by comprehensive and necessary documentation.
In addition, our technical infrastructure enables us to monitor all quality-relevant process parameters in-line and document them electronically. It goes without saying that our production facilities are validated in accordance with the requirements of ISO 13485 and are subject to preventive maintenance.
Ensuring the reliability and integrity of our systems/processes is crucial in order to prevent errors that could jeopardize the safety and efficacy of products.
With GAMP5, we address this need by providing a structured framework for the validation and maintenance of automated systems. It not only helps to meet regulatory requirements, but also improves overall operational efficiency.
CERTAINTY FOR YOUR PRODUCT
We work together with renowned, accredited laboratories for biological testing to ISO 10993, as well as the evaluation of the bioburden by quantifying the colony-forming units (CFU).
If your product requires it, we can also validate and support all of our additional services through risk management. Validation is the best way to create extra confidence in the quality of our processes and services.
Cleanliness
‘Clean and clear’ – that’s our aim here!
The danger posed by particles, fibres, or even biological contamination carries immense risks for the patient. For this reason alone, it is paramount to pay close attention to the entire scope of cleaning routines and how cleanliness is maintained.
CLEANLINESS IS A VIRTUE
The manufacture of medical devices requires the stipulation of and compliance with the appropriate ambient conditions. We have therefore defined target values for temperature and humidity for all of the relevant areas and document compliance with these electronically.
Machines and manufacturing facilities are cleaned periodically in accordance with defined procedures and only suitable and documented cleaning materials are used. Disinfection is more than just a rote activity for us – it’s paramount to how we operate. In addition, our medical team is trained in maintaining the level of hygiene required for your product. Cleanliness is more than just a virtue for us.
CLEANLINESS TAILORED TO YOUR REQUIREMENTS
All of our manufacturing facilities are divided into different sections, which range from a technically clean environment to an ISO class 7 or an EU GMP class C cleanroom. We regularly ascertain the number of colony-forming units (CFU) in the air as well as on surfaces and products. Our medical team is also equipped with the appropriate protective equipment to reduce the bioburden on your product to a minimum.
Whatever use your medical device is designed for – we offer cleanliness tailored to the requirements of your product.
CERTIFICATIONS
DRIVE OUR INDUSTRY-LEADING PRECISION ENGINEERING
To manufacture the smallest and most complex items, the technology for creating the forms must live up to the requirements. We work with a high level of automation and with highly trained employees.
From machine software to technologies for manufacturing tools – every area is designed specifically for our requirements. We collaborate with leading institutes to ensure that we always work at the highest limits of what is currently possible.
We manage a high workload every day, producing well over 70 tools each year, including maintaining ongoing production tools. This requires a modern, state-of-the-art working environment and facilities.
