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- Calibration
  
  We are one of the leading calibration laboratories in Europe and accredited for more than 300 calibration procedures according to ISO/IEC 17025:2017.
  Calibration
- Our measured variables
  Our accredited laboratories cover almost all measurands and offer a unique service portfolio.
- On-site Calibration
  We calibrate test equipment and measuring points at our customers' sites with professional competence and high-precision equipment.
- Calibration equipment
  With our portable calibrators for temperature, humidity and pressure, calibrations can be carried out regardless of location.
- Test equipment management
  
  We manage your test equipment with the holistic test equipment management solution PRIMAS for compliance with standards and directives.
  Test equipment management
- PRIMAS online
  The internet-based test equipment management system PRIMAS online supports the assurance of test equipment requirements - even while on the road.
- PRIMAS validated
  PRIMAS validated is a validation-enabled test equipment management system for companies with GxP compliance requirements.
- PRIMAS exchange
  PRIMAS exchange enables automated data transfer of test equipment data between MES/CAQ systems and our data master.
- PRIMAS connect
  PRIMAS connect is a web service for automated access and queries to PRIMAS online in the Testo Industrial Services data system.
- Qualification
  
  We support qualification projects such as cleanroom qualification or plant qualification. We also qualify warehouses and transport systems according to GDP and GSP standards.
  Qualification
- Qualification of cleanrooms
  Professional support for all GMP measures in the area of cleanroom qualification - from conception to implementation.
- Qualification of plants and utilities
  Risk-based qualification of process plants, supply systems and utilities for sustainable safety of process stability and robustness.
- Transport and storage qualification
  Storage and transport qualification to ensure uniform temperature and climate conditions and maintain product quality.
- Validation
  
  We take care of cleaning, process and transport validation as well as computer and software validation to ensure reproducibility and robustness.
  Validation
- Cleaning validation
  Holistic handling of professional cleaning validations as well as support for validation projects and revalidation measures.
- Process validation
  Risk-based process validation to demonstrate the fulfilment of process requirements and outcomes, and to ensure product quality.
- Transport validation
  Transport validation to ensure stable climate conditions during logistics and transport of sensitive goods to the consumer.
- Computer and software validation
  Computer and software validation (CSV) to ensure the reproducibility of procedures and processes of computer-based systems.

Clean room environment in a medical technology company

Outsourced processes in medical technology

According to the requirements of DIN EN ISO 13485, outsourced processes must be considered in the quality management of a medical device manufacturer. Efficient supplier management is essential to meet this requirement.

In the standard DIN EN ISO 13485 for the  medical technology specifies that the quality management of a medical device manufacturer must be extended to outsourced processes. This is to ensure that suppliers involved in one or more phases of the life cycle of a medical device also meet the regulatory requirements. This is done by monitoring, maintaining, and controlling the external processes. Since the supply chains of medical device manufacturers now often include many partner companies, efficient supplier management is essential in order to meet this requirement.

Effective supplier management

Effective supplier management can be divided into four stages: Supplier evaluation, supplier qualification, supplier selection and supplier monitoring. Special tools are available in each area. For example, a supplier questionnaire, certificates and accreditations, references, on-site audits and a quality assurance agreement can be considered and used to qualify a supplier.

By taking such a pragmatic approach to supplier management with a multi-level implementation, you can more easily keep track of compliance with regulatory requirements and successfully manage your actions.

Overview of regulations, standards and guidelines:

DIN EN ISO 13485:2016, Chapter 4.1.5 Steering of external parties
FDA-21 CFR part 820, subpart 50
MDR Regulation (EU) 2017/745, Chapter 10 (9) d
EU-GMP Guideline, Part 1, Chapter 7

Testo Industrial Services is your reliable partner in the area of "outsourced processes" for qualification, validation, calibration, documentation in the design control process and other GxP services. Contact us - together we will create an individual concept for your needs

Our service for you

Performance of a filter leakage test within the scope of a clean room qualification

Cleanroom qualification

Performance of test procedures in clean rooms according to DIN EN ISO 14644-3:2020-08

Implementation and documentation of a clean room qualification

Qualification 

Clean rooms, plants and utilities, transport, and storage

GxP-compliant validation according to the V-model

Validation 

Cleaning, process, transport, computer, and software validation