Our process-related services cover the following topics:
EN ISO 13485 / FDA 21CFR820
A key part of compliant product development is a quality management system in accordance with EN ISO 13485 (CE) and/or FDA 21CFR820 (US). On the basis of these requirements, we define the processes necessary for your company based on your companys activites and clarify the responsibilities for the process and the interfaces with other processes. In order to measure the effectiveness of the processes being implemented at all times, KPIs (Key Performance Indicators) will be defined to monitor the processes during daily operations.
We will document the processes with clearly structured SOPs (Standard Operating Procedures) and templates (checklists, forms etc.). All the processes wil be summarized in a process landscape as part of the quality management handbook.
The successful completion of the process-oriented setup of the quality management system will result in a certification in accordance with EN ISO 13485.
A certified management system is not only the basis of successful product certification, it also enables you to increase the transparency and acceptance of the various company processes in day-to-day use and to reduce the susceptibility to errors significantly.
Qualification of infrastructure and equipment
If infrastructure or equipment are used in an environment, which impacts regulatory requirements (they have either a direct or an indirect impact on the features of product performance or safety), they have to be qualified before they are put into operation.
The design (DQ), the correct installation (IQ) and then the correct operation (OQ) are checked to ensure those regulatory requirements. Measures to maintain the qualified status must also be determined after the completion of the qualification phase.
We would be happy to support you with the installation of the qualification process and to carry out qualifications of your infrastructure or equipment.
In doing so it shall be ensured that your medical devices are produced with qualified infrastructure and equipment at all times.
If the process output is not able to be tested in order to determine the quality of the production process, it must be validated in accordance with GMP (Good Manufacturing Practice) rules (PQ). This validation approach is used internationally by industry, auditors and inspectors and ensures that your production processes will be accepted as capable at any time.
We have many years of experience in the installation of risk-based and efficient validation processes and take care of your operative process validations as well.
In doing so it shall be ensured that - in case the process output is not able to be tested - your medical devices are produced using validated and therefore capable processes at any time.
Computer system Validation
(CSV) in accordance with GAMP5
Production processes which are based on computer systems must be developed and validated in accordance with GAMP5 (CSV). This validation approach is used internationally by industry, auditors and inspectors and ensures that your production processes based on computer systems will be accepted as capable at any time.
We have many years of experience in the installation of risk-based and efficient validation processes in accordance with GAMP5 and take care of your operative process validations as well.
In doing so it shall be ensured that your medical devices are produced using validated and therefore capable processes based on computer systems at any time.
Risk management EN ISO 14971 / AAMI ANSI ISO 14971
From a regulatory perspective, performing product risk management is a major task of a compliant product development. Risk aspects related to design, production process and use of the device are covered by FMEAs, and where necessary risks are mitigated subsequently. A risk management report is created on completion of the risk management activities summarizing the risk evaluation.
Knowledge obtained from the subsequent market phase must be fed back into the risk management in order to check whether risks have shifted in terms of their criticality and new measures need to be taken.
We would be happy to help you to install a risk management process in accordance with EN ISO 14971 / AAMI ANSI ISO 14971 and support you with the creation of your product risk management file or with moderation during the implementation of FMEAs.
In doing so it shall be ensured that your product risks are under control at all times.
EN 62304 / AAMI ANSI IEC 62304
Do you have stand-alone software that is classified as a medical device or is the software part of a medical device? If yes, you must meet the requirements of EN 62304 / AAMI ANSI IEC 62304 setting out the minimum requirements of the most important software lifecycle processes, such as software development, software maintenance, software risk management and software configuration management. We would be happy to help you to install a software lifecycle process in accordance with EN 62304 / AAMI ANSI IEC 62304 and to support you showing the correct use and implementation of the software lifecycle process for your device.
In doing so it shall be ensured that your device software will function perfectly and reliably in all product lifecycles.
EN 62366-1 / AAMI ANSI IEC 62366-1
Usability engineering defines the requirements of the user-device interface comprising the effectiveness, efficiency, user friendliness and therefore satisfaction of the user. The focus of EN 62366-1 / AAMI ANSI IEC 62366-1 is both on minimising the risk of poor usability and on defining a development process for usability engineering.
We are happy to help you to install a development process for usability engineering in accordance with EN 62366 / AAMI ANSI IEC 62366 and support you showing the correct use and implementation of usability engineering for your device.
In doing so it shall be ensured that the user can use your device effectively, efficiently, safely and with satisfaction.
EN ISO 14155 / AAMI ANSI ISO 14155
Medical devices may only be marketed if their performance and safety have been proven through a clinical evaluation. The harmonised standard EN ISO 14155 «Clinical investigation of medical devices on human subjects - Good clinical practice» regulates the investigations of this type.
We are happy to help you to install a process for clinical investigations in accordance with EN ISO 14155 / AAMI ANSI ISO 14155 and support you showing the correct use and implementation of clinical investigations for your device.
In doing so it shall be ensured that the use of your device is proven to be safe in clincial trial as well as in postmarket phase.
POST MARKET surveillance (PMS)
NOTIFICATIONs to authorities (Vigilance)
Post Market Surveillance (PMS) comprises the collection of information about the properties of medical devices regarding their post market use (safety, quality, shelf life, performance), the evaluation of these data, the implementation of any corrective actions which may be required for the device and where necessary the planning and implementation of safety actions on the field.
If you want to market medical devices within Europe as a manufacturer or distributor, you have to notify all all serious incidents and all recalls or other field safety corrective actions (FSCA), which have to be implemented for safety reasons, to the relevant authorities (Vigilance).
We would be happy to support you regarding implementation of a process for post market surveillance as well as the correct notifications to authorities in accordance with MEDEV 2.12-1 guidelines in the event of serious incidents.