Safety through validation. Peace of mind for your practice.
Nevertheless, validation is often perceived as complex, time-consuming, or confusing. This is exactly where Normec Valitech comes in.
Normec Valitech is your specialized partner for validation services in the field of medical devices and hygiene procedures. With nationwide coverage, a manufacturer-independent approach, and a clear focus on support and reducing your workload, we help practices ensure they are legally compliant and reliable—without unnecessarily disrupting daily operations.
Validation is required by law—and makes sense
As soon as medical instruments are cleaned, disinfected, and, if necessary, packaged and sterilized in your practice, there is a legal obligation to validate the reprocessing procedures. This obligation applies regardless of whether reprocessing is performed manually or by machine, and regardless of the size or type of equipment used. The legal basis is the Medical Device Operator Ordinance (MPBetreibV), which requires that reprocessing processes be demonstrably effective and reproducible.
Validation provides precisely this proof. It demonstrates that your processes are not only theoretically correct but also function safely and consistently in day-to-day practice operations. Up-to-date validation is a key focus of inspections and audits by regulatory authorities. With a professionally conducted validation, you demonstrate that patient safety is systematically ensured in your practice.
A fixed date each year provides clarity
As a general rule, validation should be performed every twelve months. This timeframe is recognized by regulatory agencies and professional associations as a standard and reliable review cycle. In certain cases, the interval may be extended based on a risk assessment. At the same time, there are situations in which an unscheduled revalidation becomes necessary, such as when new equipment is introduced, process flows are changed, or the practice relocates.
For most dental practices, this means one fixed validation date per year. Early planning and a reminder service help prevent missed deadlines and last-minute appointments. Normec Valitech actively supports you in this process and ensures that no appointment is overlooked.
Validation covers the entire reprocessing process
Validation is not limited to the device alone. Rather, the entire reprocessing process is examined—from pretreatment and loading through documented release to readiness for reuse. The goal is to ensure that all components are optimally coordinated and work together reliably.
As part of the validation process, Normec Valitech verifies, among other things, cleaning and disinfection performance, process parameters such as temperature and pressure, and the reproducibility of results. Routine checks, batch documentation, and work instructions are also included in the evaluation. This provides a comprehensive picture of your hygiene chain.
Efficient, practical, and with minimal disruption
A validation with Normec Valitech is clearly structured and easy to plan. Following a brief preliminary coordination, the on-site visit takes place at your practice. The necessary measurements and test runs are conducted in such a way that practice operations can continue largely uninterrupted. Our specialists collect all relevant measurement data, review your documentation, and discuss the results in a transparent and understandable manner.
You will then receive a comprehensive validation report that meets regulatory requirements and serves as reliable evidence during inspections. At the same time, you’ll gain valuable insights into the quality and stability of your processes.
Manufacturer-independent and future-proof
Many practices use equipment from different manufacturers. While this is generally not a problem, it does require manufacturer-independent validation. Normec Valitech operates completely independently of manufacturers and evaluates all equipment objectively. This allows you to remain flexible when making new purchases and avoid dependence on individual suppliers.
Flexible, transparent, and without obligations
As the market leader in manufacturer-independent validation, Normec Valitech supports medical practices throughout Germany reliably, transparently, and without contractual obligations. Practices benefit not only from fairly priced services but, above all, from a service they can always rely on: legally compliant, efficient, and tailored to their specific practice workflows.
Even with increasing requirements, tight schedules, or complex specifications, Normec Valitech ensures clarity and structure. At the same time, full flexibility is maintained—with no contractual obligations, no minimum terms, and no commitments. There are no hidden costs or dependencies on manufacturers.
This creates the freedom to focus on what really matters: secure processes, stress-free audits, and peace of mind in day-to-day practice operations.
Keep Costs Predictable Through Smart Bundling
Validation doesn’t have to be an unmanageable expense. By bundling multiple processes into a single appointment, the cost per process can be significantly reduced. As part of our partner program, travel costs are even waived entirely for four or more processes. Combined with regular reminders and independent validation, you maintain control both technically and financially.
Normec Valitech, Your Partner for Safety and Trust
Normec Valitech is one of the leading providers of validation services and water sampling for dental units. Thanks to state-of-the-art technical equipment and comprehensive in-house analyses, we guide you through the entire process—from preparation to complete documentation.
You don’t have to think of everything. We’ll remind you, guide you, and ensure that everything is in order. This gives you peace of mind for your practice and confidence during every regulatory inspection.
Normec Valitech. Safely validated. Safely supplied.
Your Partner for Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable consulting. Thanks to our comprehensive expertise, we help companies comply with laws and regulations, ensure quality, and continue to innovate with confidence.
