Real Regulatory

Strong on strategy – Strong on quality – Strong on support – Strong on success

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Real Regulatory Ltd is a team of proven and committed experts specialising in European Regulatory Affairs, Regulatory Compliance and Quality Systems.

We have a strong track record of delivering excellent results to our clients. Our focus is on completing projects on time, customising the solutions to your specific requirements, adapting to your existing processes, and generally contributing to your success through our in-depth knowledge of the relevant regulatory affairs issues.

Regulatory insight, real expertise

Our experience, team approach and certified Quality Management System ensure the delivery of accurate and efficient regulatory submissions, creating a clear pathway to commercial success.

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U MDR-2020 Deadline
The 2020 deadline for compliance with EU Medical Device Regulation (MDR) is fast approaching for medical device companies who want to remain in one of the world’s largest markets. A recent survey (June 2018) by KPMG/RAPS “The Race to EU MDR Compliance” of 200 regulatory and quality professionals at medical device companies around the world. reported the following:
• 78 % of medical device companies do not have a sufficient understanding of EU MDR.
• 58% of respondents have no strategy in place to remediate gaps in their clinical data or processes for collecting data.
• 45% of North American and 29% of European respondents were “not very confident” of being able to meet the regulatory deadline.

The survey results show that compliance with EU MDR is a major challenge for medical device companies. RRL can ensure your company is 2020 ready by guiding you through the requirements of the EU MDR and helping you develop a comprehensive EU MDR implementation plan. Contact RRL at bit.ly/2zXp9Vb and get 2020 ready now. ... See MoreSee Less

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U MDR-2020 Deadline
The 2020 deadline for compliance with EU Medical Device Regulation (MDR) is fast approaching for medical device companies who want to remain in one of the world’s largest markets. A recent survey (June 2018) by KPMG/RAPS “The Race to EU MDR Compliance” of 200 regulatory and quality professionals at medical device companies around the world. reported the following:
• 78 % of medical device companies do not have a sufficient understanding of EU MDR.
• 58% of respondents have no strategy in place to remediate gaps in their clinical data or processes for collecting data.
• 45% of North American and 29% of European respondents were “not very confident” of being able to meet the regulatory deadline.

The survey results show that compliance with EU MDR is a major challenge for medical device companies. RRL can ensure your company is 2020 ready by guiding you through the requirements of the EU MDR and helping you develop a comprehensive EU MDR implementation plan. Contact RRL at https://bit.ly/2zXp9Vb and get 2020 ready now.

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All set up for the next 2 days at ICDRA @ Clayton Hotel Burlington. Pop in and say hello! ... See MoreSee Less

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Strong on strategy – Strong on quality – Strong on support – Strong on success

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