Rq Solutions
Business Services in Pittwater
www.rqsolutions.com.au/
Remember you found this company at Infoisinfo
2-9974384?
Address
65 Dolphin Crescent Po Box 50 Cres. Avalon Beach. Pittwater, NSW, 2107.Are you the owner or manager of this company?
What you should know about Rq Solutions
Categories related to our business: services industry and quality service. Rqsolutions is a tenet of strategic professionals with over 25 years in medical device registration, therapeutic goods registration and administration, medical device consulting services, iso 13485 compliance and quality management in the health care industry. Refer to our site if you need more information.
Our forte is our continual training on updated regulatory requirements, our deliberations in various committees in association with our collaborating partners for a globalized and harmonized registration framework and the implementation of best practice excellence in Quality System maintenance. We are well obvious at both a local and global smooth with involvements with a number of companies ranging from the begin up company to multinational manufacturing facilities in Europe, US and the Asia Pacific region. Our unique core value proposition is endowed in our belief that your regular needs must be exceeded beyond your expectations and we will deliver to your requirements within your agreeable time line and budget. We take modest pride in working with our new and long term clients using a unique and differentiated relationship approach. Our Intelligence includes background information on more than 85,00 product approvals since the introduction of the stylish Australian regulations. To be advised!!.
Our local team are your experts in Medical Device Registrations for Australia. Our company old George as a consultant to perform registration of our medical devices in Australia. In any circumstances, Medical Devices are required to conform to notable regulatory requirements to ensure Quality, Safety and Clinical efficacy. The supplier is then considered to be responsible’. On the basis that the content of the GA template is not inclusive, the document can also include a reference to not only the parent product but all associated approved variances of the same product with the alike premeditated purpose. These, assist and simplify the assessment of a device’s efficacy and safety based on information provided in the associated technical file. The checklist and related clauses become the first step towards the elaboration of the technical file by the manufacturer, based on the type of device, its design, manufacture, function, composition, use, claims, and clinical evaluation. Risk assessment itself is piece of the risk management process for which, in the case of a medical device, the manufacturer is required to review on a successive basis, related documentation during the life cycle of the device. Why is risk analysis crucial for medical devices? Risk management documentation should include: It is required to yield ample and good clinical evidence that makes the device below application face the regulatory requirements in terms of safety and performance. Demonstrating substantial clinical equivalence in case of comparative clinical evidence (versus other device) based on technical, biological and clinical characteristics (generally no gap in safety and effectiveness, same design, use). Submission to PAC requires triumphant registration in the Australian Register of Therapeutic Goods(art), only comparative clinical effectiveness supported by only high quality studies with sure results in human settings (if not available, justification is needed). Regulatory process for registrations and market access. This process is straight forward as the application requires the submission of information claiming substantial equivalence to a comparator product that is already on the PL. If the device is innovative and with an application concurrently and sometimes initiated at diverse times to the GA, the application to PAC should enclose claims of superiority. There are definite and encouraging steps forward for the medical device industry regulation. The Department of Health has been working together, with consumers, health professionals, and industry in order to improve these reforms. Access other approvals for an improved decision. Our services also include extensive reports for all GA approvals to date such as specific and comparative strategic information for all Kinds of products approved for supply in Australia. This standard has evolved over time since its introduction in 2003, to what has become one of the most referenced documents in the process of establishing a successive and improving Quality Management System. The phrase Quality Management System really means that a company that has embraced the elements of ISO13485 has an established system that is continuously managing and improving its product’s quality. We will share with you the regulatory landscape for similar products in Australia and will labor with you on the most strategic tactical approach for a timely product approval. From the beginning time of being introduced to George and every situation busy together since then, I have seen nothing but very impressed
Read more...
Our forte is our continual training on updated regulatory requirements, our deliberations in various committees in association with our collaborating partners for a globalized and harmonized registration framework and the implementation of best practice excellence in Quality System maintenance. We are well obvious at both a local and global smooth with involvements with a number of companies ranging from the begin up company to multinational manufacturing facilities in Europe, US and the Asia Pacific region. Our unique core value proposition is endowed in our belief that your regular needs must be exceeded beyond your expectations and we will deliver to your requirements within your agreeable time line and budget. We take modest pride in working with our new and long term clients using a unique and differentiated relationship approach. Our Intelligence includes background information on more than 85,00 product approvals since the introduction of the stylish Australian regulations. To be advised!!.
Our local team are your experts in Medical Device Registrations for Australia. Our company old George as a consultant to perform registration of our medical devices in Australia. In any circumstances, Medical Devices are required to conform to notable regulatory requirements to ensure Quality, Safety and Clinical efficacy. The supplier is then considered to be responsible’. On the basis that the content of the GA template is not inclusive, the document can also include a reference to not only the parent product but all associated approved variances of the same product with the alike premeditated purpose. These, assist and simplify the assessment of a device’s efficacy and safety based on information provided in the associated technical file. The checklist and related clauses become the first step towards the elaboration of the technical file by the manufacturer, based on the type of device, its design, manufacture, function, composition, use, claims, and clinical evaluation. Risk assessment itself is piece of the risk management process for which, in the case of a medical device, the manufacturer is required to review on a successive basis, related documentation during the life cycle of the device. Why is risk analysis crucial for medical devices? Risk management documentation should include: It is required to yield ample and good clinical evidence that makes the device below application face the regulatory requirements in terms of safety and performance. Demonstrating substantial clinical equivalence in case of comparative clinical evidence (versus other device) based on technical, biological and clinical characteristics (generally no gap in safety and effectiveness, same design, use). Submission to PAC requires triumphant registration in the Australian Register of Therapeutic Goods(art), only comparative clinical effectiveness supported by only high quality studies with sure results in human settings (if not available, justification is needed). Regulatory process for registrations and market access. This process is straight forward as the application requires the submission of information claiming substantial equivalence to a comparator product that is already on the PL. If the device is innovative and with an application concurrently and sometimes initiated at diverse times to the GA, the application to PAC should enclose claims of superiority. There are definite and encouraging steps forward for the medical device industry regulation. The Department of Health has been working together, with consumers, health professionals, and industry in order to improve these reforms. Access other approvals for an improved decision. Our services also include extensive reports for all GA approvals to date such as specific and comparative strategic information for all Kinds of products approved for supply in Australia. This standard has evolved over time since its introduction in 2003, to what has become one of the most referenced documents in the process of establishing a successive and improving Quality Management System. The phrase Quality Management System really means that a company that has embraced the elements of ISO13485 has an established system that is continuously managing and improving its product’s quality. We will share with you the regulatory landscape for similar products in Australia and will labor with you on the most strategic tactical approach for a timely product approval. From the beginning time of being introduced to George and every situation busy together since then, I have seen nothing but very impressed
Social media
We don't have any social media account of this company
Services
Our comprehensive, extensive and up to date Regulatory Information System for all product approvals in Australia, will bear you with relevant, prompt and in depth information required for distinct and stable decision making. To be advised!! Access other approvals for an improved decision. Determine other manufacturers of similar products. As an example for medical devices, we will include complete details for manufacturers and sponsors, risk classifications with related GMDN codes applied by the sponsor and associated wording in the intended purpose worn to earnings GA approval. Continual access to the Regulatory Intelligence network is by subscription. Our services also include extensive reports for all GA approvals to date such as specific and comparative strategic information for all Kinds of products approved for supply in Australia. Planning for regular assessment and counter measures is imperative in ensuring you have a competitive advantage and the provision of improved key values to your customers. We have the information to meet your objectives and enrich your strategy. Thriving medical companies distinguish themselves from competitors through fresh and innovative solutions. When companies bundle such efficiencies with improved equipment through intelligent quality assurance, outcomes are then obvious. The ultimate benefit will be for the patient, receiving a product at a competitive price and at the highest feasible quality. This standard has evolved over time since its introduction in 2003, to what has become one of the most referenced documents in the process of establishing a successive and improving Quality Management System. The phrase Quality Management System really means that a company that has embraced the elements of ISO13485 has an established system that is continuously managing and improving its product’s quality. They are a culmination of a number of documents capturing the validated status duo of multiple processes old to construct a product. This system that manages your quality is made of the latter simple building blocks: The Quality manual that commits to a system. Commitment to constantly meeting the needs of the final user. Whole accountability to all involved in the process. Our preliminary meeting will form the basis of the regulatory strategy moving forward. We are most flexible with the initial discussions either by phone conference, at your facility or at our premises. We will share with you the regulatory landscape for similar products in Australia and will labor with you on the maximum strategic tactical approach for a timely product approval. When companies bundle such efficiencies with improved equipment through rational quality. We are maximum flexible with the initial discussions either by phone conference, at your facility or at.
Read more...
Other users also viewed:
Photos and videos
This business has no pictures or videos
Reviews of Rq Solutions (0)