We are the first Notified Body in Europe for Regulation 2019/945
ALTER TECHNOLOGY has obtained ENAC accreditation to provide conformity according to the European rules for drones intended to be operated in the open category and remote identification add-ons.
A safe flight operation starts with a preliminary assessment and flight authorization preparation. Experts from ALTER offer their complete assistance in creating the technical documentation required for a proper approach to the relevant authorities.
Technical documentation – Article 17
- The technical documentation shall contain all relevant data and details of the means used by the manufacturer to ensure that the product complies with the requirements set out in Part 1 to 6 of the Annex to the Delegated Regulation (EU) 2019/945. In addition, it shall, at least, contain the elements set out in Part 10 of the Annex.
- The technical documentation shall be drawn up before the product is placed on the market and continuously updated.
- The technical documentation and correspondence relating to any EU-type examination procedure or assessing the manufacturer’s quality system shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body.
- Where the technical documentation does not comply with paragraphs 1, 2, or 3 of this Article, the market surveillance authority may ask the manufacturer or the importer to have a test performed by a body acceptable to the market surveillance authority at the expense of the manufacturer or the importer within a specified period to verify compliance of the product with the requirements set out in Parts 1 to 6 of the Annex which applies to it.
Additionally, our proffesionals are capable of assisting an operator in this strategy by resolving technical and documentation problems.
A complete risk assessment following the SORA Methodology is the key component of the technical dossier. JARUS developed this methodology, which the International Body created to develop different rules and tools for the market, working close to EASA, our European Authority.
JARUS guidelines on SORA
Annex A – Guidelines on collecting and presenting system and operation information for a specific UAS operation.
Europe works to ensure RPAS flight operation in safety terms. SORA remarks, especially, risks on the ground and in the air with their mitigation, from the beginning, JARUS’ objectives have been oriented to operations with the minimum risks. The development of a complete analysis based on the SORA methodology is included in Annex A – Guidelines on collecting and presenting system and operation information for a specific UAS operation.
Alter Technology RPAS experts’ team, following the innovation line and the new European, tends have incorporated the risk assessment based on SORA to our pool of services for the RPAS field to facilitate this evaluation task to our clients.
We have wide experience analyzing risks and hazards throughout this methodology for operations in different categories: Open, Specific, and Certified*. Similarly, we also provide full assistance in the creation of other documents that have been requested by the authorities for a specific purpose, including manuals and the mandatory technical dossier to obtain a flight authorization, always aligned with the regulatory updates provided by the different standardization entities.
In fact, this expertise in developing technical dossiers and mandatory manuals is also applied in different projects funded by important organizations and entities. Our experience in this kind of service is already well known in the drone industry. Different stakeholders have entrusted our capabilities to obtain their permissions and special authorizations for a proof of concept.
It is important to remark the high level of commitment ALTER experts have in each service provider. The feedback is always positive, and the will to continue working together usually ends in searching for new opportunities for our clients and partners. Furthermore, our personnel is always open to solve doubts and questions related to our services and the possible needs a particular client could have.
(*) A risk assessment for Certified Category operations depends on the Authority’s requirements.