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Survey - How digital is your Regulatory Affairs System?

AstraCon is keen on improving your regulatory affairs journey. For this, we would love your active participation. Feel free to answer our survey and have a chance to win 5 free consultancy hours with one of our experts.

Conditions of participation
§1 Organiser
The organiser and responsible for the competition is AstraCon GmbH, hereinafter referred to as the “Organiser”.
AstraCon GmbH
Waxensteinstr. 50
82347 Bernried

Telephone: +49 8158 9042601
E-mail: welcome@astracon.eu

Represented by the managing directors Dr Carmen Peeß and Malin Baumgarten.

The competition is in no way connected to LinkedIn or MEDICA and is in no way sponsored, supported or organised by LinkedIn or Medica.

§2 Competition

The organiser is organising a competition. A prize will be provided for this purpose and will be awarded to the winners in accordance with the following conditions.
Participation does not require the purchase of goods or services, nor does such a purchase increase the chances of winning.

§3 Participation

The participant takes part in the competition by fulfilling the conditions of participation. This is in particular the proper completion of the entry form. There may also be other conditions that can be found in the competition publication.

Participation in the competition is free of charge. No paid services need to be used in order to participate.

Participants must always be a legal entity or partnership that must be a responsible manufacturer, distributor, importer or authorised representative in the medical device sector (MDR and/or IVDR) within the meaning of EU Regulation 2017/745 or 2017/746. Multiple entries under pseudonyms or other email addresses are not permitted and will result in exclusion from the competition.

The requirements for participation must be met for the duration of the competition. Any other method of participation than the one offered is excluded and will not be considered.

Only entries submitted during the specified period will be considered.

§4 Duration of the competition
The closing date for the prize draw is 24.11.2023.

§5 Exclusion from the competition
Employees and relatives of AstraCon GmbH, as well as existing customers and co-operation partners at the time of the competition are excluded from participation.
Participation by minors with limited legal capacity is excluded.

§6 Prizes

There are three prizes. The first winner will receive 3 hours of free consultation in the area of RA/QA for medical devices (2017/745 MDR/ 2017/746 IVDR, EN ISO 13485:2016). The second winner will receive 2 hours and the third winner 1 hour of free consultation. The prize must be redeemed within 3 months of the announcement of the winners, otherwise it will be forfeited. All participants will be assigned a number and the winners will be selected using a random number generator. No confidential data will be passed on to third parties.
The prize can only be redeemed by the winners themselves; the prize cannot be passed on or paid out.

§7 Announcement

The winners will be contacted by the organiser on 01.12.2023 using the contact details provided. A public announcement will only be made with the organiser’s consent.
If the winner does not respond after two requests within a period of 3 weeks, a new winner will be determined according to the aforementioned principle.

§8 Cancellation of the competition
The organiser expressly reserves the right to terminate the competition without prior notice and without giving reasons. This applies in particular to any reasons that would disrupt or prevent the competition from running as planned.

§9 Liability

Questions or complaints in connection with the competition must be addressed to the organiser. Contact details can be found at http://www.astracon.eu .

The organiser’s competition is subject exclusively to the law of the Federal Republic of Germany. Legal recourse is excluded.

§10 Data protection

Participants’ personal data will be recorded electronically and stored for the duration of the competition, the draw period and the prize announcement on 1 December 2023 and beyond until 31 December 2023. The data will neither be further utilised nor passed on to third parties. The data will only be stored for longer if there is explicit consent to this arising from the competition.

§Section 11 Severability clause
Should any provision of these conditions of participation be or become invalid in whole or in part, this shall not affect the validity of the remaining provisions of these conditions of participation. The invalid provision shall be replaced by a legally permissible provision that comes as close as possible to the economic meaning and purpose of the invalid provision. The same applies in the event of a loophole in these conditions of participation.