The #NotifiedBody plays a central role in the process of becoming a medical device manufacturer. We spoke to Dietmar Schaffarczyk, auditor at QS Schaffhausen AG, to find out more about what the NB expects from young #MedTech startups. Our key takeaways: ◾ NBs must maintain their independence in their assessments, which is why they must not offer direct advice. ◾ While each company must be compliant, NBs take into account the current status of a company. ◾ Long-term success can only be guaranteed by building internal expertise in addition to external support. ◾ When you first contact an NB for a QMS audit, for example, 65% of the documentation should be ready. Read the full interview here 👉 https://lnkd.in/gTvz9a5e
Medical Innovations Incubator GmbH’s Post
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Country manager at Key2Compliance | Consultants | RA/QA Medical Device | Biocompatibility| Clinical Development | Pharma QA | Training and Education | GMP | GLP | GDP | MDR | IVDR | Helping startups | CE approval | Audit
2. Regulatory workshop for MedTech startups at Danish Tech Challenge My colleague Mia Trustrup Larsen is instructor for the workshop and we have invited BSI Ingeborg Knol to talk about how the work with NB takes place and the timeline Key2Compliance #medicaldevice
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Medtech Snapshot Look Back: Glen Rabito COO of Nidus Biomedical shares with us 5 key areas startups need to be mindful of in order to keep the product development cycle moving forward. #2 covering clinical and technical risks - spot on! https://lnkd.in/gg7JbEZu #medtech #snapshot #medicaldevice #riskmanagement #startup #productdevelopment
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If you are a medical device startup, we understand the challenges you face in experimenting, de-risking, and raising the necessary capital for market entry and exit (often exceeding ~$30M). Ever wondered where a significant chunk of that capital goes? Into regulatory-related efforts. #medicaldevice #regulatorystrategy #samd #medicalsoftware #marketentry https://eliomedica.com/
Eliomedica
eliomedica.com
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If you are a medical device startup, we understand the challenges you face in experimenting, de-risking, and raising the necessary capital for market entry and exit (often exceeding ~$30M). Ever wondered where a significant chunk of that capital goes? Into regulatory-related efforts. #medicaldevice #regulatorystrategy #samd #medicalsoftware #marketentry https://eliomedica.com/
Eliomedica
eliomedica.com
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This week in Bay Area before heading to #AACC2023 in Anaheim. If you are a medical device or a biotech startup, let’s have a coffee chat. Would like to hear your story. We help medical device innovators to speed up concept-to-commercialization. Focus Areas: -Product market fit strategy -Design and development strategy -Commercialization roadmapping -DHF strategy #medicaldevice #consulting #partnershipopportunity
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📢Essential Read: "𝐁𝐮𝐢𝐥𝐝𝐢𝐧𝐠 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞: 𝐒𝐭𝐞𝐩-𝐛𝐲-𝐒𝐭𝐞𝐩 𝐆𝐮𝐢𝐝𝐞 𝐭𝐨 𝐂𝐨𝐧𝐝𝐮𝐜𝐭𝐢𝐧𝐠 𝐓𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐍𝐞𝐞𝐝𝐬 𝐀𝐧𝐚𝐥𝐲𝐬𝐢𝐬 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐒𝐭𝐚𝐫𝐭𝐮𝐩𝐬". Our latest blog post is now live! Dive into 'Building Excellence: Step-by-Step Guide to Conducting Training Needs Analysis for Medical Device Startups' for startup success! Read it here 👉https://lnkd.in/erqay8S2 In this comprehensive guide, we cover everything from regulatory considerations to practical steps for identifying training needs and developing effective programs. 💡 Plus, don't miss our insightful case study and tips to avoid common pitfalls. #TrainingNeedsAnalysis #MedicalDeviceStartups #medtech
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“Through the Regulatory Thinking® approach we have learned that the perspective "regulation is a burden" isn't true. We now understand why regulation is necessary and that it also offers useful tools and methods,” says Martin Duffner, Co-Founder of Puray and alumni of the #4CAccelerator. Does your team also want to turn the regulatory burden into an advantage? Then apply by August 4 for our free qualification program for #MedTech startups! ⏰ ➡ https://lnkd.in/eiENYKDS ⬅ Any questions? Then hit our program coordinators Lea and Christian! - The program is funded by Start-up BW, the B. Braun Stiftung - der Gesundheit neue Wege bereiten - der Gesundheit neue Wege bereiten, the Stiftung für Medizininnovationen, and the Hector-stiftung. #startupbwaccelerator
4C Accelerator Tübingen
https://mi-incubator.com
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The long and tedious patent process has become an outdated source of delay for innovators across the globe. With today’s technology, you can protect your innovations faster than ever. So when should you pursue a patent? And how can startups thrive in this rapidly evolving space? In this week’s episode, sponsored by Alpha Sophia, Bao Tran joins us to explore the crucial role patents play in the medical device startup landscape. #medtech #medicalsales #medicaldevices
From Idea to Asset: How Patents Propel MedTech Startups
medicalsalesaccelerator.com
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Join me for a webinar by L2proindia on 'Patent Due Diligence for Startups and MSMEs' on 7th Nov. 2023 at 3.00 p.m. to 4.00 p.m. This webinar aims to raise awareness of the importance of Patent Due Diligence for securing your innovations and paving the way for sustainable growth, market dominance, and enduring success. Don't just innovate, safeguard your innovations with Patent Due Diligence. The webinar aims to discuss the following: Key Components & Benefits of Patent Due Diligence Practical Strategies from Expert Speakers and Methodologies needed for Effective Patent management IP Portfolio Management and Monetization Gain practical, actionable tips tailored for Innovators, IP professionals, startups, and MSMEs. Q&A Session: Get answers to your specific queries from our expert panel. Reserve your spot now to unlock the potential of your innovations. https://lnkd.in/gd6dUmQt With Dr. Hemang Shah 💡; Anirban Mukerji; Mohd Nahid Alam; Yashpal Verkiya; YATIKA RAWAT; g keerti; Parul Chaturvedi; Ishita Srivastava; Hemangi Bhole; Sheetal Dube; Patlex Business Solutions; Pharma Literati [Part of Edu Literati]; Pankaj Kumar
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I can totally identify, as both having done startups and having worked to guide and setup others, these are worth the read. Read these 4 items again...yes they are mandatory. Would love to discuss how your startup overcame these.
Four steps medtech startups can’t put off 1)Understand your path to market -Companies need to understand the regulatory pathways and what classification their medical device is, and what are the options to market based on that classification? 2) Intellectual property -Companies need to know how to protect and understand their own intellectual property 3)Define what success looks like -What’s the goal, what’s the passion, what’s the unmet need? 4)Have a plan before problems pop up -Have a plan for how you’re going to handle problems before they arise. https://lnkd.in/gQjU7-hv
Four steps medtech startups can't put off
https://www.medicaldesignandoutsourcing.com
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