12 GHP Q3 2024 o market medical devices and in-vitro medical devices, manufacturers must ensure a compliant product, and Advena is an authority in this arena. Comprising a seasoned team of experts in quality management and regulatory knowledge, the company is the ideal partner for any manufacturer requiring advice and representation within the EU market. It’s more than earnt the accolade of Best Medical Device Regulatory Consultancy Firm 2024 – Europe. As an EU authorised representative, Advena may be appointed by manufacturers outside the EU who wish to sell and place medical devices and in-vitro medical devices on the EU market. The company acts as each client’s point of contact within the EU, able to navigate regulatory concerns on their behalf. As a founding member of the European Association of Authorised Representatives (EAAR), it’s not just enhancing clients’ operations; it’s playing a part to better the industry. Moreover, Advena prides itself on going beyond the fundamental obligations, also providing guidance, professional advice, and vital regulatory news. The team believes that simply acting as a point of contact doesn’t add sufficient value, and that helping clients to understand the latest developments is key in empowering them to make informed decisions. Through its association with the EAAR, May24294 T As EU regulations change, so too does the burden of compliance for medical and in-vitro medical devices. Ensuring that products meet regulatory standards is an increasingly complex challenge, and it’s often a costly one for companies to tackle in-house. The answer to this problem is leading regulatory consultancy Advena Limited. it’s always apprised of the latest knowledge and ready to pass it along to keep businesses running smoothly. Recent rising standards for compliance have put strain on companies producing medical equipment, and this places a heavy burden on those which don’t have the luxury of being able to delegate this increased responsibility. This includes changes to EU legislation, including new directives and regulations for both medical devices and in-vitro medical devices. Manufacturers now find it more difficult and expensive to meet regulatory demands, though Advena is always ready to step in and lower the impact of these changes. “Advena can ease the drain on your internal resources by providing cost-effective solutions. We have a very broad level of experience, offer great service, and keep our fees competitive.” Advena’s exceptional service is backed by outstanding KPIs. at 91.1% for response time, 93% for advice given, and 94.6% concerning fees, the company stands at a 93% on overall performance. It’s a prime example of a medical device consultancy which takes service seriously, and clients laud its EU REP services as swift and supportive. “We have been with Advena Ltd since 1998 and view them as a real friend to smaller companies trying to navigate the ever-changing regulatory landscape. John Adcock and his team have always been there for us with quick and solid answers to our most challenging questions. We have only ever had positive experiences along the way working with them.” “Although the journey to CE marking has been somewhat tricky, the help and assistance given from Advena has been excellent, and I’ll happily be quoted on that.” “We shifted over from an alternate authorised rep a few years ago, and the service provided by Advena far exceeds that provided by the previous authorised rep. The staff are easy to reach and work with you on whatever needs to be done.” For all medical device and in-vitro medical device consultancy needs, as well as ISO 13485 QMS consultancy, Advena is making its mark among the most informed and trusted companies around. The team alleviates EU compliance concerns at a competitive price, and it’s always up to date with the latest news to help clients stay ahead of the curve. Contact: Anthony Kirby Company: Advena Ltd Web Address: www.advena.mt Ensuring Compliance for Medical Devices and In-Vitro Medical Devices
RkJQdWJsaXNoZXIy MTUyMDQwMA==