Our product-related services cover the following topics:
CE, FDA, RoW DEVICE registrations
Do you want to register your medical device for market entry in Europe (CE), USA (510(k), PMA) or other countries?
We would be happy to take on the registration work for you, prepare the technical documentation for the device in a file, ensure that processes are compliant within the quality management system, make the submission to the notified bodies or authorities respectively and coordinate and communicate with these bodies until the device certificate has been issued.
This will enable you to obtain your product certificate following a quick, easy and straight way.
Creation of TECHNICAL FILES dhf, dmr
Do you need a device file consisting of the Design History File (results out of the Design Input, Design Output, Design Verification and Design Validation) and the Device Master Record (results out of the Design Transfer)?
We would be happy to compile you a technical file in accordance with STED (Summary TEchnical Document) based on your development results.
In doing so you can look forward to your product registration in a calm manner.
Regulatory pathway (registration strategy)
You are developing a medical device and would like to know which registration strategy would be best for the market entry.
We would be happy to advise you about the classification of your device and which regulatory pathway would be most suitable for it, regardless of whether you are planning a registration in Europe, the USA or other foreign countries.
This will enable you to set the right regulatory decisions for you medical device from the beginning.
You may be doubtful which standards you have to consider when developing your device to demonstrate regulatory compliance.
We would be happy to advise you on which laws, guidelines, standards (harmonised standards/recognized consensus standards) and guidance documents are applicable to your device. We will also support you with the correct interpretation of each applicable standard and which items need to be taken into account for your device.
In doing so it will be ensured that normative requirements are considered in the design input phase yet and your device will be developed based on state of the art.
ESSENTIAL requirements annex I / Directive 93/42/Eec
The essential requirements in accordance with Annex I of Directive 93/42/EEC must be met when registering medical devices within Europe. We would be happy to advise you which essential requirements apply to your device and which harmonised standards have to be used ensuring a presumption of conformity.
In doing so it will be ensured that the essential requirements are considered in the design input phase yet and your device will be developed based on state of the art.
EN 60601-1 / AAMI ANSI ES 60601-1
Is your medical device electrically operated or does it integrate software?
In order to ensure patient safety with regard to electrical risks and risks caused by possible software errors, the requirements of EN 60601-1 / AAMI ANSI ES 60601-1 must be met. We would be happy to advise you about the correct interpretation of this standard and derive the requirements applicable for your device.
This will enable you to address possible risks linked to the electrical part of the device or device software correctly at the beginning of your development activities and mitigate them through design measures.
EN ISO 10993-1 / AAMI ANSI ISO 10993-1
For the selection and assessment of a material or a product which is to be used on or in the human body, a structured evaluation process for biocompatibility is required following EN ISO 10993-1 / AAMI ANSI ISO 10993-1.
We would be happy to advise you about the correct interpretation of this standard and derive the requirements applicable for your device.We carry out biological test together with an affiliate testing laboratory which is accredited in accordance with EN ISO/IEC 17025 and which sisGLP certified.
This will enable you to address possible risks linked to the biocompatibility of the device at the beginning of your development activities and mitigate them through design measures.
Labelling & Packaging
Medical devices may not change their performance and safety features during transport and storage when complying with the manufacturer's instructions. Therefore the requirements for product packaging must be considered in the development process. In addition to that, the consideration of requirements for product labelling and for instruction for use are important as well.
We would be happy to support you with the implementation of a process for the development of packaging, labelling and instruction for use of your product.
In doing so it shall be ensured that your medical device is functional when the user receives it and subsequently will be able to operate it correctly and safely.