omsbar.com omsbar.com

omsbar.com

UK medical device and product design, development and manufacture, Oxford based

Omsbar provides Oxford based medical device and product design, development and manufacture services, medical device testing, medical device consultancy, validation and verification services, regulatory advice for the medical device production industry

http://www.omsbar.com/

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Omsbar Ltd

PO ●●● 79

Ox●●rd , ox14 2ys

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0123●●●● 401
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An●●●●●●●@aol.com

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Omsbar Ltd

Omsbar Ltd

PO ●●● 79

Ox●●rd , null, ox14 2ys

UK

0123●●●● 401
0123●●●● 398
An●●●●●●●@aol.com

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Claranet Ltd.

Claranet Ltd.

21 Sou●●●●●●on Row

Ho●●rn , London, WC1B 5HA

UK

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1.440●●●●●04955
ho●●●●●●●●@uk.clara.net

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UK medical device and product design, development and manufacture, Oxford based | omsbar.com Reviews
<META>
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Omsbar provides Oxford based medical device and product design, development and manufacture services, medical device testing, medical device consultancy, validation and verification services, regulatory advice for the medical device production industry
<META>
KEYWORDS
1 email enquiries@omsbar com
2 technical services
3 product design
4 prototype/small volume
5 microbiology
6 clinical trials
7 international standards
8 resources
9 compliance services
10 quality and regulatory
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PAGE
email enquiries@omsbar com,technical services,product design,prototype/small volume,microbiology,clinical trials,international standards,resources,compliance services,quality and regulatory,expertise overview,certification,welcome to omsbar,usability
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UK medical device and product design, development and manufacture, Oxford based | omsbar.com Reviews

https://omsbar.com

Omsbar provides Oxford based medical device and product design, development and manufacture services, medical device testing, medical device consultancy, validation and verification services, regulatory advice for the medical device production industry

INTERNAL PAGES

omsbar.com omsbar.com
1

Demonstrating Compliance with Harmonised and International Standards

http://www.omsbar.com/international-standards.shtml

Tel: 44 (0) 1235 814 680. Technical and compliance services. Demonstrating compliance with harmonised and international standards. EU Directives indicate that demonstrating conformance with applicable harmonised standards can be used without further justification as a means to demonstrate compliance with relevant essential requirements contained in the directives. Therefore compliance testing is a key strategy in obtaining CE Marking. Non-product related standards include for instance IEC62304 (Software ...

2

UK medical device and product design, development and manufacture, Oxford based

http://www.omsbar.com/index.shtml

Tel: 44 (0) 1235 814 680. Medical device design, build, verification and validation services. In-house prototyping and small-scale production facilities. Medical regulatory affairs including USA, EU and global registrations. Quality assurance services extensive medical device expertise. IEC60601 compliant power supplies and isolators. Compliance route determination and CE marking/510(k) strategy together with the realisation of the necessary technical, risk analysis and validation documentation. Client p...

3

Medical device prototyping and small volume production

http://www.omsbar.com/prototype.shtml

Tel: 44 (0) 1235 814 680. Prototype device manufacture and small volume production. We understand both the need for and the shortage of ISO13485 accredited facilities for the small manufacturer and the development entrepreneur. So where do you get a small quantity of medical devices manufactured, packed, sterilised and validated? Where do you find an ESD compliant electronics assembly facility? Where do you find someone who will make a prototype device? All within an ISO13485 accredited environment?

4

Designing and manufacturing IEC60601 compliant products

http://www.omsbar.com/products.shtml

Tel: 44 (0) 1235 814 680. We design and manufacture IEC60601 compliant products:. Battery packs and chargers. Signal isolators and converters. We understand the difficulty in obtaining a power supply to an exact specification which is also IEC60601 accredited. As such, our power supply designs are modular and enable multi-rail systems to be configured, normally up to about 300W. Battery packs and chargers. Signal isolators and converters. We understand the requirements of IEC60601 accreditation and are u...

5

Compliance Route Determination and CE Marking/510(k) Strategy

http://www.omsbar.com/complianceroute.shtml

Tel: 44 (0) 1235 814 680. Compliance route determination and CE marking/510(k) strategy, together with the realisation of the necessary technical, risk analysis and validation documentation. Omsbar provides compliance route determination and CE marking strategy according to the following directives:. Active Implantable Medical Device Directive. Compliance with part 2 standards (eg infusion pumps, endoscopes, etc). We also act as an EU Authorised Representative when so required. Issue 1 release Oct 2014.

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Tel: 44 (0) 1235 814 680. Medical device design, build, verification and validation services. In-house prototyping and small-scale production facilities. Medical regulatory affairs including USA, EU and global registrations. Quality assurance services extensive medical device expertise. IEC60601 compliant power supplies and isolators. Compliance route determination and CE marking/510(k) strategy together with the realisation of the necessary technical, risk analysis and validation documentation. Client p...

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