10 steps to successful CE marking

Are you an innovative startup in the medical device of medtech industry and feel a bit overwhelmed by the Medical Devices Regulation in Europe?

Do you more or less understand this regulation, you are aware of the available guidance documentation, but do not know how and where to start?

This workshop can be the answer to the questions you have on where to start, what to do, and when to do it. In this workshop, you will learn which steps to take in which order, the key issues to address and pitfalls to avoid. You will learn about the intended purpose of a medical device, the choice of notified body, device classification, the use of (harmonized) standards, the technical documentation, the quality management system, and last but not least the clinical evaluation. After this workshop you will understand what evidence is needed and be able to build up your CE marking strategy.

Bio trainer Danielle Motta

Daniëlle is Head of Global Registrations & Consultant at Qserve Group.

Daniëlle joined the Qserve Group in 2017 and has since supported manufacturers with market access worldwide. She knows what is needed for an effective strategy for CE marking of medical devices which can be lodged to an extend for global registrations. Daniëlle is responsible for the Global Registrations department; a team of regulatory affairs associates and consultants supporting manufacturers with their in-country registrations in APAC, EMEA and LATAM, ensuring effective communication with competent authorities, and designing market access strategies suitable to the manufacturer’s technical documentation available whilst keeping a practical approach. Daniëlle has a MSc. Science, Business and Innovation in Life & Health Sciences.

Specific topics and questions

If you want to participate in this workshop and have specific questions or topics you would like to know more about, do not hesitate to send them to info@briskr.nl. They will be forwarded to the trainer.

Location
We organize this workshop at Noviotech Campus in Nijmegen. There is a free parking lot at Jan Massinkhal at the other side of the street.

Good to know
We finish off by joining the great BBQ from Kadans (Kadans Summer Event). This workshop is free of charge and facilitated in English. We welcome new contacts, so feel free to share this invite with your network! Please register upfront!

The importance of solid general terms & conditions in contracts and agreements

Clear contracting
During this interactive workshop Daniek and Jan Willem from our supporting partner Poelmann van den Broek advocaten will discuss the importance of clear contracting. They will talk about common issues and pitfalls regarding contracting and general terms & conditions and will provide tips on how to deal with this.

Topics
Term and Termination possibilities
Intellectual Property
Liability
Exclusiveness
Confidentiality

Of course there is ample opportunity for the participants to bring in examples and ask questions.

Presenters
Daniek Regterschot, paralegal at Poelmann van den Broek Advocaten
Jan Willem van Aken, paralegal at Poelmann van den Broek Advocaten

Daniek and Jan Willem are both specialized in commercial contracts, Intellectual property rights and IT-contracts. They advise large to medium-sized companies when entering into various types of agreements such as purchasing and sales contracts, supply contracts, licence agreements, collaboration agreements, non-disclosure agreements and general terms & conditions.

Don’t miss this workshop, sign up below!

Location
We organize this meeting at Noviotech Campus Nijmegen, free parking is possible at the Jan Massink Hal on the other side of the road.

This workshop is free of charge. We welcome new contacts, so feel free to share this invite with your network!

Tax Aspects About Hiring People: Risks and Opportunities

Join us for our workshop on Tax Aspects About Hiring People. Gain valuable insights into the tax implications of hiring people, including the risks and opportunities for optimizing your tax position. The experienced professionals of our partner BDO will cover the highlights of a broad selection of topics such as:

Basics of payroll taxes and compliance requirements;
Overview of the advantages and disadvantages regarding hiring employees versus hiring freelancers;
Basics of the Dutch WKR regulation;
Overview of a Stock Appreciation Right (SAR) versus an Employee Participation plan (EPP) and its benefits whether or not combined with a STAK.

This workshop is a unique opportunity to learn from experts in the field from the Briskr network.

Trainer
Bernard de Vree, Tax Advice Manager

Graduated in accountancy, tax economics and tax law
Almost 15 years of experience as an accountant and tax adviser within SMEs
Affinity with the dynamics of developing innovative companies
Practical and proactive sparring partner

Good to know
We finish off with drinks & bites. This workshop is free of charge and facilitated in English. Please register upfront!

Location: Noviotech Campus in Nijmegen, Building M.

We welcome new contacts, so feel free to share this invite with your network!

Visit Business Metropole Ruhr to Nijmegen

On 29th of March Business Metropole Ruhr brought a visit to the Nijmegen health ecosystem.

Business Metropole Ruhr is a metropole region of over 5 million people with many healthcare companies, hospitals and other care activities. As such the area is an interesting area to expand internationally due to the close proximity to Nijmegen and the high population density.

During the visit an overview was given on the activities in Nijmegen by Jan van Dellen (director Economic Board), John van Sambeek (Civic Entrepreneur Economic Board), Martijn Kriens (program manager Briskr) and Bert Krikke (director Noviotech Campus). The visit will lead to further activities to support mutual business on both sides of the border.

As a first step Business Metropole Ruhr will give a workshop on doing business in Germany and Briskr will give a workshop in Germany on how to approach the Dutch healthcare market.

Interested in internationalisation to Germany, contact martijn.kriens@icrowds.net

Kennislunch Open Hiring

Heb jij je al aangemeld voor de ION-Kennislunch? Graag brengen we deze interactieve en impactvolle bijeenkomst nog even bij je onder de aandacht. Onder het genot van een lekkere lunch kom je meer te weten over Open Hiring.

Wat houdt het precies in? Wat zijn de voor- en nadelen? En kan deze aanpak jouw organisatie helpen bij het uitbreiden van jouw personeelscapaciteit?
Verder staat tijdens de lunch ons nieuwe ION-lid MuZIEum centraal. Zij vertellen je meer over (werken met) een visuele beperking. En laten je zelf ervaren hoe het is om een visuele beperking te hebben.

Natuurlijk is er tijdens de lunch voldoende ruimte om in gesprek te gaan met andere ION-leden en inclusieve ondernemers. Ben jij er ook bij op 17 april?

Programma
12.15 – 12.30 Inloop
12.30 – 12.40 Opening door Ivo Hermsen, bestuursvoorzitter ION
12.40 – 13.00 Maak kennis met Open Hiring
13.00 – 14.00 Kijk, luister en ervaar – MuZIEum

Praktische informatie
De kennislunch vindt plaats bij de Noviotech Campus, Transistorweg 5 (gebouw M) in Nijmegen. Er is voldoende gratis parkeergelegenheid bij de Jan Massinkhal tegenover de campus.

Aanmelden kun je via deze link. Dit is kosteloos.

Webinar: Intellectueel eigendom in al zijn vormen

Intellectueel eigendom (IE) is de verzamelnaam voor rechten die uitgewerkte nieuwe ideeën en creatieve concepten beschermen. Zo kunt u voorkomen dat iemand anders uw idee of product zomaar kopieert.

Maar wanneer kunt u uw idee beschermen, met welk recht doet u dat en hoe vraagt u zo’n recht aan? Belangrijke informatie voor creatieve denkers, ondernemers en innovators.

Tijdens ons webinar op maandag 24 april om 15:00 uur leggen Thomas Remmerswaal en Mandy van Overeem het u haarfijn uit.

Tijdens het webinar behandelen zij onder andere:

Welke vormen van IE er zijn
Hoe u deze rechten verkrijgt
Wanneer en bij wie u ze aan kunt vragen
Welke bescherming ze bieden en hoelang deze van kracht zijn

We nodigen u van harte uit om op maandag 24 april om 15:00 uur deel te nemen aan dit webinar. Uiteraard is er tijdens en na afloop gelegenheid om vragen te stellen.

Meer informatie en aanmelden

Benelux RF Conference

24 MAY 2023 – VAN DER VALK NIJMEGEN

The Benelux RF Conference brings together Belgian and Dutch high-tech professionals and companies involved in the development and application of high-end RF techniques. The seventh edition will take place on Wednesday 24 May 2023 at Van der Valk Nijmegen.

Join The Economic Board & Briskr at the Health Valley Event on 30 March in Nijmegen.

This healthcare innovation event is the meeting place for everyone involved in innovations, entrepreneurship and science in Life Sciences and Health. We will also be present with a stand and warmly invite you to drop by for information and a good chat.

The Economic Board and Briskr share a stand
Briskr supports start-ups in Health/Hightech with networking events, coaching, workshops and funding search. Find out more about this at the stand.
Staff from The Economic Board team will be happy to tell you more about the commitment to a strong Health and Hightech cluster. Are you working in a triple helix context on an initiative that fits within the spearheads and ambitions of our Health and Hightech sector? Meet us and possibly make an appointment to discuss how we can support your project.

Transition in Healthcare
The theme of this year’s Health Valley Event is: Transition in healthcare.
Health developments, which are necessary for a liveable future, are not possible without the influence of the high-tech sector, which provides the basis for innovations with its key technologies.
The event will discuss the need for prevention, the opportunities for the right care in the right place, the opportunities for value-driven care, the challenges on the labour market and the affordability of care.

At this event, you can:
– Get inspiration from top keynote guests such as Ernst Kuipers, Maroeska Rovers, Sietske Rozie and Chris vanoof.
– Follow one track, including: Right care in the right place, prevention, value-driven care, labour market and affordability of care.
– Expand your (inter)national network amidst 1000+ participants.
– Discovering the latest innovations on the exhibition floor.
– Make a connection at one of the one-to-one matchmaking meetings.

Stop by our stand (number 25) for a chat and something more fun. Don’t miss out!

https://www.healthvalleyevent.com/

Transitie in de zorg centraal bij Health Valley Event 2023

Na de succesvolle hybride editie van het Health Valley Event in 2022, vindt op donderdag 30 maart 2023 een nieuwe editie plaats. Het event is dit keer uitsluitend live op locatie te bezoeken in Pathé Nijmegen. Health Valley, hét zorginnovatie ecosysteem van Oost-Nederland, organiseert jaarlijks het grootste zorginnovatie event van Nederland, om de ruim 1000 deelnemers uit binnen- en buitenland samen te brengen. Dit jaar staat het event in het teken van de grote transitie in de zorg, met onder andere top keynote gasten zoals Ernst Kuipers, Maroeska Rovers, Sietske Rozie en Chris van Hoof.

Chris Doomernik, directeur Health Valley: “De gezondheidszorg staat onder druk en dat merken we allemaal. Er liggen kansen die we vandaag moeten grijpen om ook morgen goede en tijdige zorg te garanderen. Wij richten ons in deze zorgtransitie op het versnellen van innovatie met inzet van technologie. Met ons jaarlijkse event, zorgen we ervoor dat onze bezoekers face-to-face nieuwe verbindingen kunnen leggen met ondernemers en mensen die actief zijn bij zorgorganisaties, kennisinstellingen en overheden. Dit alles met het doel om mensen langer te laten leven in goede gezondheid!”

Thema’s: betaalbare en toegankelijke zorg

Op het Health Valley Event zoomen we in diverse sessies, maar ook de beursvloer, dieper in op betaalbare en toegankelijke zorg van vandaag en morgen, ondersteund door technologische innovaties. Laat je inspireren door top keynote gasten zoals Ernst Kuipers, Maroeska Rovers, Sietske Rozie en Chris van Hoof. Zij kijken naar de noodzaak van preventie, naar de kansen voor de juiste zorg op de juiste plek en naar de mogelijkheden voor waardegedreven zorg. En we gaan aan de slag met de uitdagingen op de arbeidsmarkt.

Tickets en programma

Op de website van het evenementen is meer informatie terug te lezen over de beursvloer, de diverse sessies en matchmaking mogelijkheden. Er zijn nog tickets verkrijgbaar voor het event, kijk op www.healthvalleyevent.com.

Health Valley Event

Het Health Valley Event is hét grootste zorginnovatiecongres van Nederland. Jaarlijks komen bezoekers uit binnen- en buitenland uit zowel de zorg, het bedrijfsleven, onderzoek, onderwijs als overheden bij elkaar om te werken aan de gezondheid en zorg van morgen. Op het event staat het uitwisselen van kennis, maar ook het opdoen van inspiratie en vooral matchmaking centraal.

FPGA technology: a perfect solution for AI, IoT and system integration challenges

Next to CPUs and GPUs, FPGAs occupy an increasingly important place in modern processing platforms. In this meeting we will highlight the benefits of an FPGA technology and how to optimally benefit from its features.

During the sessions we will address questions such as:what exactly can you do with an FPGA, for which applications is FPGA technology specifically suitable, what distinguishes FPGAs from CPUs, GPUs and AI accelerators?

Heterogeneous chip solutions, utilizing both FPGA technology and CPU, are becoming more commonly used. What benefits does this provide and how can you use them?

The aim of the afternoon is to shed light on these subjects from different angles.