It will happen to you too.

Maybe not today or tomorrow, but it will happen, an unannounced audit from your Notified Body.

Unannounced audits by the Notified Body (NB) are performed without any prior notice or schedule. The auditor can show up at any time and expect to have access to your premises and documentation related to your medical devices, including IVD devices. A Notified Body also has the right to visit your suppliers or subcontractors to check their compliance with applicable requirements and the status of the Quality Management System (QMS). In some cases, the auditor can also take product samples for further examination and analysis.

Unannounced audits can be very stressful and disruptive for your company, but there are ways to make them less stressful and chaotic.

  1. First and foremost, keep your compliance high at all times.
    The best way to avoid any problems during an unannounced audit is to always maintain a high level of compliance with your quality management system and relevant regulations and standards.
  1. Organize your documentation.
    This is of course a part of the above, but your documentation and records are essential for proving your compliance. You should therefore keep them continuously organized and accessible since you won’t have any time for “housekeeping” before the audit.
  1. Have a plan or even better a SOP or instruction for unannounced audits.
    Before the audit happens, you should have a clear plan on how to handle an unannounced audit. The SOP should include how to greet the auditor and confirm their identity. Confirming that the unknown person at your door is who they claim they are is extremely important. So, make sure you outline who is responsible for what, how to communicate with the auditor, and how to escalate any issues if they occur. And don´t forget to assign back-ups for people who might not be available on that particular day.
  1. Train your staff.
    Your staff should be aware of the possibility and the purpose of unannounced audits, and they should know how to act professionally and cooperatively with the auditor. This does of course not differ from any other audit, but the lack of preparation time can cause high stress among staff.
  1. Monitor your critical suppliers and include unannounced audits by NB in your contracts.
    Your suppliers and subcontractors are also part of your quality management system, and they may be subject to unannounced audits by the notified body as well. You must therefore be able to show that you monitor their performance and compliance regularly. You also need to inform your critical suppliers about the potential of unannounced audits by the notified body and agree on how to handle them.

The above tips will help you to demonstrate your commitment to quality and safety in case of an unannounced audit. But it will also increase your confidence and reduce the stress that always comes with an audit, but even more when it comes unannounced.

If you have any question, contact us at info@qadvis.com.

Does quality and regulatory pose a challenge to Innovation?

Quality and Regulatory Affairs is often regarded as being a hindrance to innovation. We think this is a very counterproductive way of looking at it. We see the QMS more like the barrier between the opposite lanes of the motorway preventing you from a head on collision in case of an innocent mistake.

Sweden is a home to over 600 medical technology companies, employing five people or more, and collectively providing employment to over 50,000 individuals. A nation of just 10 million people, has been the birthplace of a remarkable number of inventions that have left an indelible mark on the world. It may seem that all it takes is a brilliant idea to make a significant impact, but the reality of medical device development is more complex. Regulatory compliance is a critical aspect of this process, that ensures user safety, maintains quality, and secures market approval. However, far from being a hindrance, regulatory compliance can enhance innovation efficiency and open up new opportunities for innovation. It’s all about finding the right balance between regulation and innovation. Thepurpose of regulatory affairs is to secure market access for a safe and effective product as quickly and painlessly as possible – not to hinder innovation. And that is exactly our cup of tea, Regulatory compliance with the least burdensome approach. The number of companies that we have helped and continue to help is our legacy of success. We are proud that we have the opportunity to support several top-rated medical device companies in Sweden.

The list of Swedish contributions to the world includes significant inventions such as the ball bearing, refrigerator, adjustable spanner, and the three-point seatbelt, just to mention a few.

The country has also made significant strides in the software realm, with globally recognized contributions like the game Minecraft, Bluetooth technology, Skype, and Spotify.

In the healthcare sector, Sweden’s contributions to the 20th century have been nothing short of transformative. The world’s first clinically usable artificial kidney was developed in 1946, followed by the Servo ventilator in 1950, medical ultrasound in 1953, the implantable pacemaker in 1958, and the Gamma knife in the late 60s.

More recent innovations include the Bone Anchored Hearing Aid (BAHA) in 1977, the Turbuhaler® Inhalator in 1987, and the Lucas Chest Compression System® that provides mechanical chest compressions to patients in cardiac arrest, introduced in Swedish ambulances in 2003. Medical devices have a huge impact on the lives of patients everywhere. It is therefore important that innovation, quality and regulatory affairs co-work and not counteract each other.

If you have any question, please contact us at info@qadvis.com.

 

The 26th of May 2024 is soon here!

Ensure that your Quality Management System (QMS) is up to date and in line with the EU/EEA Medical Device Regulation (MDR) before 26th of May 2024.

Many medical device manufacturers, obliged to have a Notify Body acceptance and supervision, are still in the process of transfer from MDD to MDR and intend to use the advantages of further extension of MDD certification from its current Notified Body.  To be able to use this advantage, application to your Notified Body for MDR assessment needs to be in place before the 26th of May 2024 and the achievement of an agreement no later than 26th of September 2024.

In addition, do not forget your Quality Management System (QMS) which is required to be in line with requirements stated in MDR no later than May 2024. A QMS certified according to EN ISO 13485:2016 also most likely needs additions and adjustments to fulfill MDR.

To establish, implement, maintain, and improve the QMS to ensure compliance with both the ISO 13485:2016 and MDR in an effective way, is not always obvious. There are often a lot of considerations to ensure that the QMS fulfills the purpose for the organization and applicable requirements.

If you need a second opinion or a GAP analysis of your current QMS in relation to the MDR requirement, contact us at info@qadvis.com for more information.

 

Our team is growing.

We start 2024 with a warm welcome to our new team-members, Ekaterina Riabova and Lee Ambolt to our office in Lund.

QAdvis is happy to welcome Ekaterina and Lee to our growing team of experienced quality and regulatory consultants. This strategic expansion is a testament to our commitment to continuous growth and to be able to meet the current and future quality and regulatory requirements in a sector that is ever-evolving.

Their collective background within the medical device sector, especially with clinical evaluation and SW, ensures that our consulting services remain at the forefront of innovation and compliance.

If you want to learn more about Ekaterina and Lee and their experiences and how QAdvis can contribute to your business, contact us at info@qadvis.com or call us at + 46 86 21 01 05.