UKCA Marking vs CE Marking – FAQ
The Clever Compliance Blog
by Katrin Troeva
1y ago
What is UKCA marking? The UKCA marking is a new UK product conformity marking that is mandatory for different types of goods placed on the market in Great Britain. It covers most goods which previously had to be CE marked – for example, medical devices, electrical equipment, toys, aerosols, machinery, etc. The UKCA marking officially came into effect in January 2021. However, businesses were given time until the end of December 2022 to adjust to the new product safety requirements. Until then, CE marking is still valid in the UK. The goods that are required to have the new UKCA mark affixed on ..read more
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Exporting to Saudi Arabia: Product Certification & the SASO Saber System
The Clever Compliance Blog
by Katrin Troeva
2y ago
This article focuses on import procedures in Saudi Arabia and what foreign manufacturers need to do to pass customs and sell their goods in the country. It also provides information about the SASO Saber system. I. Why export to Saudi Arabia? Saudi Arabia is among the biggest economies in the Middle East and the world’s top 25 economies. The country provides businesses with major opportunities for trade and investment in traditional sectors such as oil and gas and in sectors like healthcare, transportation, education, mining, water and wastewater projects, and nuclear energy. In addition, Sau ..read more
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Understanding the Moroccan Cم (CMIM) Mark
The Clever Compliance Blog
by Katrin Troeva
2y ago
This article provides manufacturers with information on the Moroccan Cم (CMIM) mark and lists some digital sources where they can stay updated with the changes in the local legislation. I. What is the Cم (CMIM) mark? The Cم (CMIM) mark certifies the regulatory conformity of products offered for sale on the market in Morocco. The certification marking is mainly used to ensure the safety of industrial goods on the Moroccan market. Its operative texts set out the legal requirements for those products. Once obtained, the CMIM mark approval doesn’t need to be renewed as long as the following two ..read more
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Understanding the UKCA Marking (FAQ)
The Clever Compliance Blog
by Katrin Troeva
2y ago
I. What is the UKCA marking? The UKCA marking is a new UK product conformity marking used for goods placed on the GB market (England, Scotland and Wales). It covers most products, which previously needed the CE marking. The new marking came into effect on January 1st, 2021. However, companies selling already CE marked goods in the UK can postpone the UKCA certification until the end of 2023. Please note that the European Commission doesn’t recognise the UKCA marking and, thus, products bearing only the UKCA marking aren’t allowed for sale on the EU market. II. What products need to have UKCA ..read more
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Misbranded & Adulterated Medical Devices – FDA
The Clever Compliance Blog
by Katrin Troeva
2y ago
The following sections provide information on misbranded and adulterated medical devices. What are adulterated medical devices? An adulterated medical device is any product that has been corrupted or debased by incorporating an impure or spurious substance. The FDCA has expanded this definition by adding that a product may also be adulterated due to: the defective nature of an inherent characteristic of the device itself, the conditions surrounding the device, even if there may be nothing intrinsically wrong with the device itself. Adulterated medical devices have several intrinsic qualities ..read more
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Safety-Critical Components: General Information & Relevant UL Standards
The Clever Compliance Blog
by Katrin Troeva
2y ago
This post contains information on what safety-critical components are and a list of UL standards applicable to various safety-critical parts implemented in the design of electrical equipment. I. What are Safety-Critical Components? Safety-critical components are elements that are critical to the safety of electrical equipment, and their failure could create a hazardous situation. Generally, these components help prevent any injuries or damages due to the applicable hazards that may occur during the production, packaging, transporting, installation, usage and/or service of an electrical product ..read more
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11 Severe FDA Compliance Actions & Penalties
The Clever Compliance Blog
by Katrin Troeva
2y ago
The FDA has various enforcement tools at its disposal to deal with violations of an FDA regulation. The following sections provide summary information on the main FDA compliance actions and the type of penalties that may apply. The federal agency performs many tasks in carrying out its compliance responsibilities. For instance, the FDA oversees product recalls, inspects manufacturing facilities, and monitors the implementation of preventive and corrective actions. The FDA also conducts various activities in support of its compliance responsibilities short of taking action against a medical d ..read more
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Understanding the BXM Method
The Clever Compliance Blog
by Katrin Troeva
2y ago
I. What is the BXM method? Compliant with ISO 14971, the BXM method helps you decompose a medical device system, perform risk analysis on the parts of the system and then integrate the underlying studies into the primary system-level analysis. System decomposition The decomposition should follow the system architecture. For instance, you can use the BXM method to decompose a system into two main parts. Then each of the parts you can further decompose into multiple components and so on. Refer to the figure below. In addition, there are two criteria for system decomposition you need to consider ..read more
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What is Pre-control and Positrol Verification?
The Clever Compliance Blog
by Katrin Troeva
2y ago
Pre-control and positrol are two methods manufacturers need to use to verify the supplier quality process performance. This article provides readers with brief information on each of these methods. I. What is pre-control? Pre-control verification is about controlling the supplier quality process during production to prevent the manufacture of defects. You can use this method after completing the product qualification process. Pre-control is a considerably simple method to use as you can teach it to an operator in 10 minutes. This method can help you keep processes running hundreds of thousan ..read more
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7 Elements Essential for Product Liability Prevention
The Clever Compliance Blog
by Katrin Troeva
2y ago
Product liability prevention is about understanding what to do and how to do it to achieve product safety excellence. For that reason, this article provides information on what product liability is and how to prevent it. I. What is Product Liability? Product liability describes an action in which a product user seeks to recover damages for harm from a seller or manufacturer when it is claimed that the harm resulted from a defect in the product. Thus, without a product defect, there is no product liability. Product defects can be defects associated with the design, manufacturing or marketing ..read more
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