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International Medical Device Regulation Support

RookQS can provide international regulatory support to help expand the reach of your device. We have helped dozens of medical device companies grow their sales internationally through both quality and regulatory support.

RookQS’ seasoned, robust team of quality and regulatory experts will help your company achieve international device approval in all major medical device markets, including United States, Europe, U.K, Brazil, Canada, Japan, Australia- and any other markets of interest- through on-site audit support and regulatory communication.

International Medical Device Regulations

Medical device regulations vary by country and region, but in general, most countries have some form of regulations in place to ensure the safety and effectiveness of medical devices. In the United States, for example, medical devices are regulated by the Food and Drug Administration (FDA), which evaluates the devices for safety and effectiveness before they can be sold to the public. In the European Union, medical devices are regulated by notified bodies, they correspond to a country in the EU and assess the conformity of certain products before being placed on the market.

International Regulatory Affairs Experts

By virtue of working in so many different markets, RookQS fully understands complex international regulations and when and how they overlap. We work with each of our clients in developing customized and in-depth regulatory strategies that leverage your current quality management system. We also assist with conducting and monitoring the implementation of your revised quality management system, training your employees, and on-going compliance and maintenance of your QMS.

Sustaining regulatory and quality compliance across multiple markets is demanding, while also submitting to regular quality system audits. The Medical Device Single Audit Program (MDSAP) allows an MDSAP-recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. International partners that are currently participating in MDSAP include TGA Australia, Brazil, Health Canada, Japan, and the US. RookQS offers on-site audit preparation, training, and mock audits for both MDSAP and ISO 13485.

With a dozen certified auditors as part of our team, we understand what notified bodies and external auditors are looking for, how they interpret the regulations being followed, and how closely guidance documents are being regarded. RookQS assists in creating your documentation, gap analysis, and responding to notified bodies. With the US FDA intending to harmonize the current U.S. Quality System Requirements with the ISO 13485 standard, the regulatory landscape is evolving towards a risk-based quality system. Some markets recognize certification to ISO 13485, whereas others require compliance to country-specific requirements.

No matter where you plan to market your products, RookQS can help establish a QMS that meets the specific requirements of all the countries in which you intend to sell your product.

MDR Section

The EU MDR is the European Union Medical Device Regulation 2017/745. There have been substantial changes from the MDD to the MDR. Look to Rook to assist with assorted needs like transitioning from MDD to MDR, expanding from the US into the EU market, or putting together technical documentation from scratch.

Sustaining regulatory and quality compliance across multiple markets is demanding, while also submitting to regular quality system audits. The Medical Device Single Audit Program (MDSAP) allows an MDSAP-recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. International partners that are currently participating in MDSAP include TGA Australia, Brazil, Health Canada, Japan, and the US. RookQS offers on-site audit preparation, training, and mock audits for both MDSAP and ISO 13485.

With a dozen certified auditors as part of our team, we understand what notified bodies and external auditors are looking for, how they interpret the regulations being followed, and how closely guidance documents are being regarded. RookQS assists in creating your documentation, gap analysis, and responding to notified bodies. With the US FDA intending to harmonize the current U.S. Quality System Requirements with the ISO 13485 standard, the regulatory landscape is evolving towards a risk-based quality system. Some markets recognize certification to ISO 13485, whereas others require compliance to country-specific requirements.

No matter where you plan to market your products, RookQS can help establish a QMS that meets the specific requirements of all the countries in which you intend to sell your product.

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