Your needs regarding the European MDR / IVDR and Global Medical Device Regulations

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Lean Entries (www.leanentries.com), together with Tiger Accelerator & BioHub Taiwan, holds a 1 hour event on 15 December titled "Mastering the Health Tech Business: MDR & IVDR Compliance as a Business Advantage". Please follow this link to subscribe to the event: https://en.tigeraccelerator.com/single-post/masterclass-mdr-ivdr-2021-en

BioHub Taiwan integrates interdisciplinary resources into the NBRP Academy to cultivate business talents and provide business mentoring. Our major goal is to push impactful fundamental research into commercialization.

With this form we intend to collect general information about your company, team and product in relation to the European and global medical device regulations. By understanding your challenges, we will be able to provide the most suitable regulatory contents. The information is collected anonymously, unless you choose to indicate your company name and contact information.

PLEASE ANSWER THE QUESTIONNAIRE BY 13 DECEMBER. Thank you and welcome to the event!

Please describe your company.

Manufacturer (with legal responsibility of the product, which carries our name and logo on the label)

Supplier or subcontractor of hardware or software to medical device or other manufacturer(s)

Distributor or importer of medical devices or other goods

Other:

Please indicate under which regulation does your product fall locally or globally

Medical device regulations

In vitro diagnostic (IVD) medical device regulations

The product falls under other regulations (e.g. the medicinal product regulations)

The product does not fall under any such regulations

Not sure if these regulations apply to our products, or which of these regulations should be applied

Other:

Clear selection

Please describe your product type:

Electromedical

The product is software or contains software

Machine learning / Artificial intelligence software

Implantable or surgically invasive

Therapeutic

Diagnostic

Other:

Is your product on the market?

Yes, in Europe (CE marked)

Yes, in Taiwan

Yes, in other regions

No, we are developing the product

No, we have an idea of a product or are at an early stage of development

Other:

Please describe your level of knowledge regarding medical device regulations and requirements in general

Very little knowledge

Basic knowledge

Substantial practical knowledge

I'm a regulatory expert

Other:

Clear selection

Which of these topics are you interested of learning more about if we organise more regulatory training?

EU MDR / IVDR in general

Clinical investigations related to EU MDR

Clinical evaluation

Risk management

Design control / Requirements for product development

Software life cycle management

Other:

Your contact information (name, title, company, email, phone number), if you wish to share them with us:

Submit

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