PROVIDING EVIDENCE. BEING TRANSPARENT. – Regulatory as interdisciplinary business strategy.
Our Approach.
New manufacturing methods that promise unimagined freedom in design and development, but also in production and distribution, software to be used as medical application or artificial intelligence as part of IVDs or medical devices often inspire bold ideas. To establish these ideas as products on the market in a faster, more efficient, and more sustainable way different partners came together as a consortium and developed Regulatory Thinking® as a mindset of an interdisciplinary business strategy and its development.
Using regulatory requirements of the healthcare market as a strategic opportunity – that is the essence of Regulatory Thinking®. It is an open-minded certification strategy, respecting rules and regulations but giving enough freedom to apply common specifications to future technologies.
„This is the only way to free medical device manufacturing from traditional process constraints.“ (Dietmar Schaffarczyk, Certified Lead Auditor & Startup Founder)
Company Details
- Employees
- 4
- Address
- Zürich, Ch
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.ai4mdr.com
- Keywords
- MDR, IVDR, Medical Device Certification, CRO Clinical Studies, Software Development SaMD, DiGA, BfArM, Clinical Safety and Performance Endpoint, Regulator Thinking, ISO 13485, ISO 14971, ISO 62366, Certification Strategies, Risk Management, Technical Assessment, Audits, Training & Coaching, Regulatory Canvas, Reimbursement Strategies, Safety and Performance Assessment.
- HQ
- Zürich
Regulatory Thinking® Questions
Regulatory Thinking®'s website is http://www.ai4mdr.com
Regulatory Thinking®'s LinkedIn profile is https://ch.linkedin.com/company/regulatory-thinking
Regulatory Thinking® has
4 employees.
View email and phone details for 4
employees at Regulatory Thinking®.
Regulatory Thinking®'s industry is
Business Consulting and Services
Regulatory Thinking®'s top competitors are
Mangold Medtech Consulting,
Stirnweiss | Brenner Rechtsanwälte,
Stiftung Für Medizininnovationen,
Biloop Consulting,
Casebase Health,
Medical Innovations Incubator Gmbh,
Sync2brain Gmbh,
African Yatom Charity Organization,
Cg Controlling Gmbh,
Sprintray Inc..
Regulatory Thinking®'s categories are Business Consulting and Services
