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Eabling health care

Provide consulting services and training to medical device developers and manufacturers.

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Eabling health care | hazelview.com Reviews

https://hazelview.com

Provide consulting services and training to medical device developers and manufacturers.

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About | Hazelview

http://hazelview.com/about

44 (0) 2081 443 423. Hazelview is the name that we use to offer consulting in Bioengineering and services in regulatory compliance for a range of technologies used in health care, from innovative medical devices, such as implants, combination products and software to rehabilitation aids and equipment for health and sports training, or a range of in vitro diagnostic (IVD) devices for laboratory applications or self testing by patients. How to contact us. You can write to us in total confidence using our e...

2

Training | Hazelview

http://hazelview.com/training

44 (0) 2081 443 423. The type and level of training you need depends on the scope of your activity and how the learning outcomes of any training fits into the requirements of that activity. In other words, you need to have done a training needs analysis (TNA) before you source training. Alternatively we can do the TNA for you through our consulting work. Through the submenu items you can browse the pages. For more specific information. Which is the best way to meet those obligations and avoid liability?

3

Regulation or Standard | Hazelview

http://hazelview.com/knowledge-to-manage/eu-regulation/regulation-or-standard

44 (0) 2081 443 423. The EU legislation, for example the MDD, provides one method of compliance with its requirements as being the implementation of relevant EU harmonised standards. This means that if a manufacturer implements EN 13485 (Medical Devices Quality Managment Standard) it is presumed that the manufacturer complies with the requirements of the MDD. This can become a source of misunderstanding which is seen as equating a standard with legislation. On 20/04/2017 at 11:14 am. Six − two =.

4

US Regulations | Hazelview

http://hazelview.com/knowledge-to-manage/us-regulations

44 (0) 2081 443 423. Medical devices are mainly regulated by CFR-21 parts 800 – 1299. There is, however, copious references to parts of the FD&C Act as well. For example the famous 510(k) submission is based on section 510(k) of the FD&C Act. When compared to the regulations in Europe, it is easy to see that the US regulation of medical devices is very prescriptive and can be very detailed. Transcript - 3/17/17 Ophthalmic Devices Committee https:/ go.usa.gov/x5YGw #fda #medicaldevice. 5 × two =.

5

CFR-21 | Hazelview

http://hazelview.com/knowledge-to-manage/us-regulations/cfr-21

44 (0) 2081 443 423. Title 21 of Code of Federal Regulations in the US, defines the main compliance requirements for medical devices. It is made of many parts but only those most relevant to our work are outlined below. Production and process controls. Corrective and Preventive actions. Class I, II and III. Description of the device. The non-clinical and clinical studies. Discussion and analysis of data. Transcript - 3/17/17 Ophthalmic Devices Committee https:/ go.usa.gov/x5YGw #fda #medicaldevice.

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44 (0) 2081 443 423. The above phrase fully describes what we do. We enable health care by taking technologies to clinical applications. We apply our skills and experience to transform clinical needs into technical requirements and we help scientists and engineers to meet those requirements. Class I Medical Device Recall: Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly. On 24/03/2017 at 4:00 am. Please enter an ...

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