HOFFMAN HEALTHCARE CONSULTANCY

Pharmaceutical and Medical Device Industry Information, Help and Guidance

Hoffman Healthcare Consultancy are here to help pharmaceutical and medical device companies to achieve excellence.

As part of our commitment to supporting others in bringing great healthcare to all, we are building this information hub to aid you in keeping up to date with the ever developing standards and regulations, alongside our first-rate knowledge, expertise, and friendly guidance.

  • Interview: Regulatory Expert Simon Hoffman | AXOL Bioscience

    Moving towards in vitro from a regulatory perspective: Considerations from the FDA Modernization Act 2.0 Axol Bioscience caught up with Simon Hoffman, Principle Quality Assurance & Regulatory Consultant to hear what he thought of the FDA Modernization Act 2.0 and how it will impact drug discovery. Here’s a snippet from the interview. Q Thanks for your time, Simon.… Read more

  • How to Maintain a Traceability Matrix

    Advice from our founder, Simon Hoffman, on how to maintain a traceability matrix, using 7 top tips. We can’t emphasise number 4 enough! When it comes to your Design History Files/Technical Files you need to maintain a traceability matrix. This must document: What we have discovered: Some clients find maintaining the traceability matrix overwhelming and… Read more

  • FDA June 2023 Update

    FDA June 2023 Update – Guidance document for Content of Premarket Submissions for Device Software Functions. This guidance document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions? As part of our commitment to supporting others in bringing great healthcare to all, we… Read more

  • MHRA Update April 2023

    MHRA Update – References MHRA update – In April 2023, the MHRA released the referenced guidance which was updated primarily to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023. This guidance has been updated with changes to: ‘UKCA marking’ ‘Labelling requirements’ ‘Registrations in… Read more

  • The Key to a Successful Inspection

    Stock up on tea and coffee, it’s that time again. The inspectors are coming. Minimise the chance of follow-up and repeat visits. The key to a successful inspection is preparation. 👉 Correct & up to date documents Have inspections in mind the moment you receive the green light for a project. Start those required documents,… Read more

  • Don’t Pester the Inspector

    Waiting for an FDA, EMA or MHRA competent authority inspection? Don’t pester the inspector. We know it’s tempting to ask lots of questions to gain as much information as possible, however: Before contacting the inspector, first, check the authority blogs and pages. Some of the generic information you require may already be available so worth checking… Read more

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