Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Articles

Home
Blog Standard
Page 25
12Jul 2024
EU, Regulations admin

EU MDR – Article 117

EU MDR – Article 117 – The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological...
Read More
12Jul 2024
EU, General Information, Regulations Cubicdesignz

Smart Wearables Regulations in the EU 

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation. Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place. How are these general we...
Read More
12Jul 2024
EU, EU MDR admin

Manual on Borderline and Classification of Medical Devices

New guidelines on how to distinguish between medical devices and medical products under the Medical Devices Regulation have been published by a working group of the European Commission (MDR). The new recommendations from the European Medical Device Coordination Group (MDCG) cover “borderline products” that are difficult to classify as either medical devices subject to the MDR requirements or medical products for human use subject to the requirements of Directive 2001/83/EC (MPD) for CE...
Read More
12Jul 2024
EU MDR, EU Cubicdesignz

Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices

According to European Union Medical Device Regulation (EU MDR) the term “Vigilance” is the identification, reporting and trending of serious incidents and the conduct of safety-related corrective actions (Market surveillance and vigilance). An ‘incident’ as per article 2(64) MDR is any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supp...
Read More
12Jul 2024
Brazil, Regulations admin

Updates in ANVISA GMP 2022 document 

Agência Nacional de Vigilância Sanitária – ANVISA is the Regulatory Body of Brazilian government.   What is Good Manufacturing Practice (GMP)?  Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices.  The GMP document released on 30th March 2022 for Medical and IVD produ...
Read More
News July 10, 2024 admin

June Newsletter 2024 – Hebrew

אנו נרגשים לשתף אתהאחרונות בניוזלטר יוני שלנו!מה יש בפנים!!עדכונים על תקנות ותאימות של מכשירים רפואייםתקני בטיחות ומגמות עדכניות בתעשייה של מוצרי קוסמטיקהקבל תובנות לגבי אישורי תרופות וחדשות שוקקרא מידע מפורט למטה:June Newsletter Hebrew...
Read More
News July 10, 2024 admin

June Newsletter 2024 – Japanese

6 月のニュースレターで最新の更新情報と洞察を共有できることを楽しみにしています。中身は何だ！！1. 医療機器の規制とコンプライアンスに関する最新情報2. 化粧品の安全基準と業界動向3. 医薬品の承認と市場ニュースに関する洞察を得る以下の詳細情報をお読みください。June Newsletter Japanese...
Read More
News July 10, 2024 admin

June Newsletter 2024 – Korean

6월 뉴스레터에서 최신 업데이트와 통찰력을 공유할 수 있기를 기대합니다.안에 뭐가 들어있어요! !의료기기 규정 및 규정 준수에 관한 최신 정보화장품 안전기준 및 산업동향약물 승인 및 시장 뉴스에 대한 통찰력 확보아래에서 자세한 내용을 읽어보세요.June Newsletter Korean...
Read More
News July 10, 2024 admin

June Newsletter 2024 – Simplified Chinese

我们期待在六月时事通讯中分享最新的更新和见解。里面是什么！ ！有关医疗器械法规和合规性的最新信息化妆品安全标准及行业趋势深入了解药品审批和市场新闻请阅读下面的更多信息。June Newsletter Chinese (Simplified)...
Read More
News July 10, 2024 admin

June Newsletter 2024 – Chinese (Traditional)

我們期待在六月時事通訊中分享最新的更新和見解。裡面是什麼！ ！有關醫療器械法規和合規性的最新信息化妝品安全標準及產業趨勢深入了解藥品審批和市場新聞請閱讀下面的更多資訊。June Newsletter Chinese (Traditional)...
Read More

Enquiry Now

    This will close in 0 seconds