Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm

Get In Touch:

Get In Touch:

Articles

Mpox: Origin, Global Impact, Testing, and Solutions

Mpox, formerly known as monkeypox, is a viral zoonotic disease that has rapidly emerged as a global health concern. The mpox virus, a member of the Orthopoxvirus genus, was first identified in humans in the Democratic Republic of the Congo (DRC) in 1970. For decades, the disease was mostly confined to Central and West Africa, where it remained endemic. However, beginning in the spring of 2022, mpox began spreading to countries outside of Africa, regions that had rarely seen cases in the past. Si...
Read More

EU Declaration of Conformity

The Declaration of conformity (DoC) is one of the key documents within technical documentation. Technical documentation is necessary for manufacturers as this is a detailed record that provides essential information on the design, manufacture, and operation. EU Declaration of Conformity is signed by the manufacturer to declare that the products comply with the EU requirements. By signing it, the manufacturer takes full responsibility for the product’s compliance with the applica...
Read More

Whitepaper: The Future of the Global In-Vitro Diagnostics (IVD) Market: Trends, Challenges, and Opportunities

This white paper explores the global In-Vitro Diagnostics (IVD) market, focusing on the next five years. It covers the most sold devices, countries with high procurement, complexities faced by manufacturers, market evolution, and the impact of regulations. The insights provided are based on current market trends and data. Topics Covered in this Whitepaper 1. Introduction 2. Overview of the Global In Vitro Diagnostics Market 3. Complexities Faced by Manufacturers 4. Evolution of IVD Market 5. Imp...
Read More

July Newsletter 2024 – Japanese

2024 年 7 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。中には何があるんだ! !1. 医療機器の法規制・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. 2024 年 7 月の更新された ISO 規格のリスト詳細については、以下をお読みください。July Newsletter Japanese...
Read More

July Newsletter 2024 – Korean

2024년 7월 뉴스레터에서 최신 업데이트와 유용한 정보를 공유할 수 있기를 기대합니다.안에 뭐가 들어있어요! !1. 의료기기 규정 및 준수에 관한 최신 정보2. 화장품 안전기준 및 업계동향3. 2024년 7월 업데이트된 ISO 표준 목록자세한 내용은 아래를 읽어보시기 바랍니다.July Newsletter 2024 - Korean...
Read More

July Newsletter 2024 – Chinese (Traditional)

We look forward to sharing the latest updates and insights in our July 2024 Newsletter. What’s inside! ! 1. The latest information on medical device regulations and compliance2. Cosmetics safety standards and industry trends3. List of Updated ISO Standards for July 2024 Please read below for more information. July Newsletter Chinese Traditional...
Read More

July Newsletter 2024 – Chinese (Simplified)

We look forward to sharing the latest updates and insights in our July 2024 Newsletter.What's inside! !1. The latest information on medical device regulations and compliance2. Cosmetics safety standards and industry trends3. List of Updated ISO Standards for July 2024Please read below for more information.July Newsletter Chinese Simplified...
Read More

Cosmetic Regulatory Requirements in Sweden

In Sweden, cosmetic products are regulated primarily under the framework of the European Union (EU) legislation, specifically Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safety and compliance of cosmetic products across the EU member states, including Sweden. Medical Products Agency (MPA) In Sweden, the Medical Products Agency (MPA) or Läkemedelsverket is responsible for overseeing the regulation of cosmetic products. The MPA ensures that cosmetic products pla...
Read More

What makes Switzerland significant for Medical Device Manufacturers?

Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland’s choice of EMEA headquarters for industry leaders. The country boasts one of the world’s highest proportions of GDP derived from the manufacturing sector, driven by traditional watchmaking, MEMS, and Medtech industries. These sectors have cultivated highly industrialized, digitized precision cluste...
Read More

Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.” The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III)....
Read More

Enquiry Now


    This will close in 0 seconds