Essays about: "Regulatory Affairs"

Showing result 1 - 5 of 7 essays containing the words Regulatory Affairs.

1. 1. The crisisification of the European Single Market : A study investigating how changes to governance of the Single Market can be understood through crisisification

   University essay from Försvarshögskolan

   Author : Julia Linder; [2024]
   Keywords : crisisification; Single Market; European crises; institutional changes; security and risk;

   Abstract : The European Single Market (SM) has typically been a symbol of economic integration and multilateralism within the European Union (EU). It operates within a robust regulatory framework aimed at ensuring the free movement of goods, services, people, and capital. READ MORE

3. 2. MedTech Firms' Business Model Alignment with Healthcare Institutional Logic : Successful Commercialization

   University essay from Luleå tekniska universitet/Institutionen för ekonomi, teknik och samhälle

   Author : Ida Rehnström; [2021]
   Keywords : MedTech; medical technology; business model; business ecosystem; legitimacy; regulatory affairs; public affairs; procurement; digitalization; healthcare institutional logic; institutional misalignment;

   Abstract : MedTech firms experience barriers when entering the healthcare sector, although their solutions could solve healthcare challenges. The study provides a conceptual framework for MedTech firms' business environment including institutional alignments and misalignments. READ MORE

4. 3. Development of Medical Device : A Narrative Literature Review

   University essay from Uppsala universitet/Institutionen för samhällsbyggnad och industriell teknik

   Author : Azhar Fuadi Siregar; [2020]
   Keywords : product development model; medical device; healthcare;

   Abstract : The Stage-gate model has long been used in product development. Alternatives to Stage-gate such as Design Thinking and other models have been developed which are flexible and consider users’ needs early on and thus they could be more suitable for medical device development. READ MORE

5. 4. MDR 2017/745 - New EU Regulation for Medical Devices: A Process Description for EHR Manufacturers on How to Fulfill the Regulation

   University essay from KTH/Medicinteknik och hälsosystem

   Author : Frida Germundsson; Nicole Kvist; [2020]
   Keywords : MDR; regulation; process description; EHR system; CE mark; medical technology;

   Abstract : On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. READ MORE

6. 5. Policy Instruments and their Impact on Business Practice in the Fashion Industry towards Sustainability : Learning Outcomes from the Food Industry

   University essay from Högskolan i Borås/Akademin för textil, teknik och ekonomi

   Author : David Dreker; Jacqueline Lampey; [2019]
   Keywords : Policy Instruments; Regulatory Affairs; Public Procurement; Textile Industry; Sustainability; Control Instruments; Knowledge Transfer;

   Abstract : The fashion industry is not only known for its creativity and innovation, but also for its contribution to environmental pollution, climate change as well as for social imbalances and poverty. Ecological and societal standards have so far only played a minor role in this industry for production and distribution as well as for consumers for their consumption and disposal behaviour. READ MORE