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Building Technical Documentation Effectively

Product development is an all consuming process, taking considerable time and effort. An important activity associated with product development is the building of Technical Documentation to support your medical device for regulatory submissions. Technical Documentation is used describe a medical device and specify how a manufacturer has demonstrated that the product is safe and performs as they intend it to (in normal conditions). Building Technical Documentation is a complex and detailed task. Some key factors, which feed into Technical Documentation, to consider in the early stages as part of product development are......

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Planning is Key for Regulatory Success

Planning is a recognised and vital step in the development of any medical device…. planning of design, manufacture, customer requirements … the list goes on. However regulatory requirements are often disregarded until submissions for certification is required. The regulatory framework surrounding medical and IVD devices is complex – insufficient planning from the beginning can result in significant delay and cost for manufacturers and distributors who haven’t factored regulatory requirements into their overall plan.  Whether we like it or not, regulatory compliance is a vital piece of the pie when it comes to......

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KD&A - How Can We Help you in 2014?

KD&A provide expert medical device and IVD regulatory guidance to help launch products and access new markets. Our services include regulatory strategy, product registration for Australian (TGA), EU (CE Marking), United States (FDA) and Canadian markets, as well as ISO and GMP quality system compliance. Regulatory Strategy Development of a sound regulatory strategy is an essential starting point for medical device and IVD manufacturers. Designed to provide your organisation with an understanding of specific regulatory requirements in chosen target markets, a Regulatory Strategy Report is your road map to market. Quality Management......

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Therapeutic Goods Administration (TGA) Introduce Online Medical Device Incident Reporting (MDIR) System

The TGA have introduced a new online MDIR System for sponsors and manufacturers which is accessible via their eBusiness system (also used to submit applications). The eBusiness system can only be accessed by companies who have completed a TGA Client Details Form to establish themselves with the TGA (and have the necessary eBusiness username and password). The System is designed to improve ongoing reporting and monitoring for adverse events which have been reported to the TGA using the online adverse event incident reporting form (acessible here or from an eBusiness account). The......

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Medical Device Single Audit Program (MDSAP)

The International Medical Device Regulators Forum (IMDRF) began work on developing documentation to facilitate the Medical Device Single Audit Program (MDSAP) in Singapore in 2012. The Pilot Program is now due to begin in 2014 and will bring a new era for medical device manufacturers. The global approach to consistent audit requirements is hoped to facilitate improved monitoring of devices and reduce burden for manufacturers. The MDSAP is designed to ensure a single audit of a medical device manufacturer will provide efficient and thorough coverage of the diverse international regulatory requirements of......

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Time for a Regulatory and QMS Tidy Up

2013 is quickly drawing to a close – ensure you carry out a regulatory and quality management system (QMS) tidy up within your organisation before the Christmas break is here. KD&A recommend the following tasks: Complete product registration for medical devices (including IVDDs) that your organisation wish to place on the market in 2014. Ensure all outstanding QMS activities are seen to. Review registers and forms to ensure they’re suitably complete. Consider scheduling internal auditing, standards review, post market surveillance and management review activities for 2014 – adding reminders to your diary......

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EU: Uncertain Regulatory Landscape

Formal decisions which will shape the future regulatory landscape of the EU are yet to be made by officials. Significant change is on the horizon however it is difficult to say when and how this will play out.  Information being released shows the EU remains indecisive however the concepts of a centralised regulatory body and two regulations to replace the Medical Device Directive, IVD Directive and Active Implantable Device Directive are well and truly looking likely. Stay tuned for further updates as the EU grind slowly towards to a safe and efficient......

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Technical Documentation: What is it all about?

Technical Documentation is a vital component of gaining regulatory certification for all medical devices, including in vitro diagnostic devices (IVDDs).  Technical Documentation often called a Technical File, Design Dossier, or STED (Summary Technical Documentation) describes a device,  including the intended purpose, history, design, manufacture and validation.  Manufacturer’s use Technical Documentation to confirm that their device is safe and effective in carrying out its intended purpose, and conforms to regulatory requirements. Technical Documentation is generally developed in line with the internationally acknowledged Standard Technical Documentation (STED) guidelines created by the Global Harmonisation Task......

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