kdas.com.au
KD&A – Regulatory consultants for Medical and IVD Deviceskd&a specialise in expert medical device and IVD regulatory guidance to help launch products and access new markets.
http://kdas.com.au/
kd&a specialise in expert medical device and IVD regulatory guidance to help launch products and access new markets.
http://kdas.com.au/
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KD&A – Regulatory consultants for Medical and IVD Devices | kdas.com.au Reviews
https://kdas.com.au
kd&a specialise in expert medical device and IVD regulatory guidance to help launch products and access new markets.
kdas.com.au
Post-Market Surveillance | KD&A
http://www.kdas.com.au/services/post-market-surveillance
Regulatory consultants for Medical and IVD devices. Call us today 61 4 11 101 392. Take the difficulty out of on going compliance using a KD&A Post Market Surveillance System. It is a requirement that all medical devices and IVDs included on the ARTG be monitored whilst on the Australian market. Post-market monitoring is a combination of proactive and reactive actions, and is a mandatory regulatory requirement. AUD$1,250 plus GST. If you require a custom quote. Have a few questions? Like to know more?
Technical Documentation: IVD and Medical Devices | KD&A
http://www.kdas.com.au/services/technical-documentation
Regulatory consultants for Medical and IVD devices. Call us today 61 4 11 101 392. Let KD&A help you with the development of Technical Documentation that complies with the medical device regulations. Technical documentation is a requirement for all medical device and IVD products – KD&A, as an expert medical device consultant, can assist you with the development of technical documentation for your device that complies with the applicable medical device regulations. KD&A will create high quality tech...
International Manufacturers | KD&A
http://www.kdas.com.au/international-manufacturers
Regulatory consultants for Medical and IVD devices. Call us today 61 4 11 101 392. To place a medical device or IVD on the Australian market, non-Australian based manufacturers must appoint a local agent and obtain Therapeutic Goods Administration (TGA) certification. The TGA term for a local agent is a ‘sponsor’. Recommended Route to Regulatory Compliance. Lodge an Application for ARTG Inclusion. This application will be dependent on device type and classification, and will be submitted to the TGA. ...
Australian Distributors | KD&A
http://www.kdas.com.au/distributors
Regulatory consultants for Medical and IVD devices. Call us today 61 4 11 101 392. A distributor selling medical devices or IVDs on the Australian market, you are considered a “sponsor” by the Australian regulator, the Therapeutic Goods Administration (TGA). Before selling medical devices or IVDs in Australia, you are required to obtain TGA certification, known officially as Australian Register for Therapeutic Goods (ARTG) Inclusion. Recommended Route for Regulatory Compliance. Prior to supplying your me...
Quality Management System: Medical and IVD Devices | KD&A
http://www.kdas.com.au/services/quality-management-system
Regulatory consultants for Medical and IVD devices. Call us today 61 4 11 101 392. Get the best from your organisation by implementing a KD&A Quality Management System. Any Australian manufacturer of a medical device or IVD higher than a Class I must have a Quality Management System. These systems are required by regulators in most regions because they define and control how medical products are developed, documented, released, modified, manufactured, traced, maintained, and also recalled. Employee train...
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Regulatory Consulting Partners - Phil Triolo and Associates
http://www.philt.com/partners.html
Providing expert medical device and pharmaceutical packaging regulatory consulting since 1997. Special Areas of Expertise. MT Promedt Consulting GmbH. Is a Germany-based regulatory consultancy operating in the international health care market (Medical Device, In-vitro Diagnostics, Pharmaceutical and Biotechnology Industry). Founded in 1995, the company operates two German offices in St.Ingbert / Saarland and Tornesch / Schleswig-Holstein and a US office in Salt Lake City/Utah. KD&A Pty. Ltd.
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KD&A – Regulatory consultants for Medical and IVD Devices
List Your Medical Device for Sale on The Australian Market KD&A. Medical and IVD Devices. Device and IVD Companies. Australia Medical Device and IVD Companies. At KD&A we specialise in designing ISO 13485 Quality Management Systems and Technical Files for medical devices and providing support with the TGA Conformity Assessment process. Australian Importers And Distributors. International Medical Device And IVD Companies. EU (CE Marking),. United States (FDA),. Latest articles from our Blog. E : kdent@kda...
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More options ▼. Subscribe to my blog. Created: 01/02/2011 at 11:44 AM. Updated: 12/03/2012 at 1:27 PM. Peut de chose sur moi . Juste rien a fire . Don't forget that insults, racism, etc. are forbidden by Skyrock's 'General Terms of Use' and that you can be identified by your IP address (66.160.134.4) if someone makes a complaint. Please enter the sequence of characters in the field below. Posted on Sunday, 11 March 2012 at 2:04 PM. Please enter the sequence of characters in the field below. Une Vu du hau...
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