OLKON Consulting

Happy New Year! 🎉🥂 Wishing all our clients, partners, and colleagues a joyful and successful 2025. Thank you for being part of our journey this year! Here’s to new opportunities and continued success in the year ahead. #OLKON #NewYear

Are you familiar with the Unique Device Identification (UDI) system for medical devices? 🔍 The UDI is more than just a code - it’s a gateway to ensuring traceability and safety in healthcare. Let’s take a closer look at how it works and why it’s crucial! 🔹What makes up the UDI? It’s composed of two key elements: UDI-DI (Device Identifier): Manufacturer-specific and device-specific, offering access to essential device information. UDI-PI (Production Identifier): Identifies the production unit and, if needed, the packaging. 🔹The UDI System in Action The implementation involves: 1️⃣ Marking the device or its packaging with the UDI. 2️⃣ Ensuring storage of the UDI by economic operators and healthcare professionals. 3️⃣ Leveraging the UDI database for seamless electronic management. 🔹Key players Manufacturers, authorized representatives, and importers must submit UDI data related to devices and economic operators. 🔹But what about the Basic UDI-DI? 🤔 It’s the core access key to device-specific data in the Eudamed database and links directly to essential documentation like certificates, EU declarations of conformity, and technical files. Changes in the Basic UDI-DI trigger changes in the UDI-DI, ensuring accuracy and up-to-date information. The UDI-DI is visibly placed on the device label, packaging, and, in the case of reusable devices, the device itself. Let’s embrace the UDI system for its role in improving medical device safety and traceability. Have questions about UDI or its implementation? Let’s talk! 💬 #OLKON #MedicalDevices #UDI

Ever wondered how vehicles stay protected from cyberattacks? 🤔 When it comes to automotive cybersecurity, attacks generally fall into two categories: passive and active. Passive Attacks: These focus on secretly intercepting data. For example, a MITM (Man-in-the-Middle) attacker might position themselves unnoticed between two communication points, gathering sensitive information without anyone realizing it. Active Attacks: These go a step further. Here, attackers don’t just listen; they manipulate. They might alter, delete, or inject data - or even block key functions - to disrupt or take control of vehicle systems. Five Common Attack Methods: 1️⃣ Spoofing: Impersonating a trusted source to gain sensitive info. (e.g., Faking CAN identifiers so an ECU believes it’s receiving legitimate commands.) 2️⃣ Replay: Using previously captured data to trick systems into responding to outdated commands. (e.g., Replaying older diagnostic data to influence engine performance.) 3️⃣ Tampering: Modifying firmware or system configurations to degrade safety or functionality. (e.g., Altering ECU firmware to make the vehicle unsafe or inoperable.) 4️⃣ Denial of Service (DoS): Overloading the network so critical components can’t function, effectively disabling the vehicle. (e.g., Flooding CAN bus with high-priority messages to block other ECUs.) 5️⃣ Side-Channel Attacks: Exploiting indirect sources of data (like power consumption patterns) to uncover encryption keys and compromise vehicle operations. These are just a few examples of how cybercriminals might target a vehicle. Staying one step ahead requires awareness, robust security protocols, and ongoing vigilance. Curious to learn more or need guidance in protecting your systems? Reach out to us - we’re here to help. #OLKON #Automotive #Cyberattack

At OLKON, we see ourselves as the connection between groundbreaking innovation and seamless compliance. Our mission is to be your trusted partner when facing challenges from rising technical complexities and the need to meet regulatory and industry standards. Take your business to new heights with OLKON and shape the future together!🚀 #OLKON #Innovation #Compliance

EU Cyber-Resilience Act The EU's Cybersecurity Regulation (CRA) is a landmark regulation that aims to strengthen cybersecurity in the European market by imposing strict cybersecurity requirements for all digital products and connected devices. This includes hardware, software, and all other products with digital elements that are directly or indirectly connected to a network. The CRA defines products with digital elements as any software or hardware product and its remote data processing solutions that include software or hardware components. The products covered under the CRA must either directly or indirectly connect to a network or device. ⏹️ The act categorizes products into two main groups based on risk levels: 🔹 Non-critical products: These include low-risk hardware and software, such as hard drives, smart home assistants, and connected toys. 🔹 Critical products: These are further divided into Class I (lower risk), such as VPNs and routers, and Class II (higher risk), including operating systems, smart meters, and mobile phones. Critical products are subject to more stringent security measures. Some products, such as medical devices and software-as-a-service (SaaS), are excluded unless part of a larger solution involving digital elements. Importantly, free open-source software used in non-commercial contexts is not covered by the regulation. ⏹️ Key Points: 🔹Cybersecurity by Design 🛡️: Manufacturers will be required to implement security measures from the development stage and maintain them throughout the product's lifecycle. 🔹Lifecycle Obligations 🔄: Manufacturers must provide security updates for up to five years or for the expected lifespan of the product, ensuring vulnerabilities are addressed proactively. 🔹Incident Reporting 📢: Organizations will need to report significant cybersecurity incidents and vulnerabilities within 24 hours to national Computer Security Incident Response Teams. 🔹Global Impact 🌍: The CRA’s requirements extend to non-EU companies that sell products in the EU market, making this regulation a potential global standard for cybersecurity, influencing businesses worldwide. The CRA is expected to be fully enforced by 2027, following a transition period after its anticipated adoption in early 2024. This regulation will enhance Europe’s cyber resilience and set a global benchmark for digital product security. #OLKON #Cybersecurity #Regulation

Navigating Regulations and Strategies for Sustainability 🌍 In Europe, companies must adhere to a range of regulations and standards aimed at managing energy compliance and emissions. This framework is essential for promoting sustainability and ensuring that businesses contribute to the EU's environmental goals. 🔹Key Regulations · EU Emissions Trading System (ETS) 🌐: This cap-and-trade system limits greenhouse gas emissions from various sectors. Companies are allocated allowances that they can trade, encouraging reductions in emissions. · Energy Efficiency Directive (EED) ⚡: The revised directive (EU/2023/1791) establishes a binding target for EU countries to achieve an 11.7% reduction in energy consumption by 2030. It mandates energy audits for large companies and promotes energy management systems. · Industrial Emissions Directive (IED) 🏭: This directive sets limits on emissions from industrial activities and requires the use of Best Available Techniques (BAT) to minimize pollution. · Corporate Sustainability Reporting Directive (CSRD) 📈: Effective from 2024, this directive requires large companies to disclose their environmental impacts, including emissions from energy use. 🔹Compliance Strategies · Conduct Regular Energy Audits 🔍: Companies must perform energy audits to identify inefficiencies and opportunities for savings. · Implement Energy Management Systems 🔄: These systems help monitor and optimize energy consumption, ensuring compliance with efficiency requirements. · Invest in Renewable Energy ☀️: Transitioning to renewable sources can help companies meet regulatory targets and reduce their carbon footprint. · Engage with Regulatory Bodies 🤝: Understanding local regulations and maintaining communication with regulatory authorities is crucial for compliance. Energy compliance is a critical aspect for companies operating in Europe, driven by stringent regulations aimed at reducing emissions and promoting sustainability. By understanding key directives and implementing effective strategies, businesses can not only comply with legal requirements but also enhance their operational efficiency and contribute positively to environmental goals. 🌱 #OLKON #Sustainability #Regulations #Strategies

📢 Latest Updates from the Medical Device Coordination Group! In October five new guidance documents were released, covering topics such as: 1. Corrective and preventive actions (CAPA) plans 2. Qualification of in vitro diagnostic medical devices 3. Application of MDR requirements to legacy devices 4. Distinctions between medical devices and medicinal products 5. Regulatory status of ethylene oxide sterilization Stay informed to ensure compliance and uphold safety standards in the medical device industry. For assistance with these updates, feel free to reach out to us! #OLKON #MedicalDevice #Updates

The importance of ISO standards in the pharmaceutical industry In the pharmaceutical industry, adherence to ISO standards is critical for ensuring the quality, safety, and efficacy of products throughout their lifecycle. The International Organization for Standardization (ISO) provides a comprehensive framework that guides pharmaceutical companies in various aspects of their operations, from research and development to manufacturing and distribution. ⏹️ Key ISO Standards in Pharmaceuticals 🔹 ISO 9001:2015: This standard establishes requirements for quality management systems, emphasizing customer satisfaction and continuous improvement. 🔹 ISO 14644-1:2015: Focuses on cleanroom environments, essential for maintaining product integrity during manufacturing. 🔹 ISO 15195:2018: This standard outlines requirements for laboratories performing quantitative testing, ensuring accuracy and reliability in measurement processes. 🔹 ISO 17025:2017: This standard specifies the general requirements for the competence of testing and calibration laboratories, vital for ensuring accurate and reliable testing results in drug development. 🔹 ISO IDMP Standards: A set of five standards designed to uniquely identify medicinal products globally, enhancing communication and regulatory compliance across borders. These include: - ISO 11238 (Substances) - ISO 11239 (Pharmaceutical dose forms) - ISO 11240 (Units of measurement) - ISO 11615 (Regulated medicinal product information) - ISO 11616 (Regulated pharmaceutical product information) 🔹 GMP (Good Manufacturing Practice): It is not an ISO standard, but it ensures that products are consistently produced and controlled according to quality standards. Its primary goals are to minimize risks associated with pharmaceutical production that cannot be eliminated through testing alone. ⏹️ Benefits of ISO Certification 🔹 Enhanced Credibility: Certification demonstrates a commitment to quality and safety, boosting a company's reputation in the global market. 🔹 Regulatory Compliance: Adhering to ISO standards helps ensure compliance with both local and international regulations, facilitating smoother market access. 🔹 Improved Processes: Implementing ISO standards leads to streamlined operations, reducing inefficiencies and enhancing productivity. ⏹️ Conclusion The integration of ISO standards in the pharmaceutical industry is essential for maintaining high-quality production and ensuring patient safety. As regulatory landscapes evolve, adherence to these standards will continue to be a cornerstone of operational excellence in pharmaceuticals. #OLKON #Pharmaceutical #ISOStandards

Why is Food Safety Important?🔏 Food safety (or food hygiene) is used as a scientific method or discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. Foodborne illness (food poisoning) is any illness resulting from the contamination of food by pathogenic bacteria, viruses, or parasites and toxins. Symptoms vary depending on the cause. They often include vomiting, fever, and aches, and may include diarrhea. Food manufacturers shall consider the 5️⃣ key principles of food hygiene, according to WHO. These are: 1.    Prevent contaminating food with pathogens spreading from people, pets, and pests. 2.    Separate raw and cooked foods to prevent contaminating the cooked foods. 3.    Cook foods for the appropriate length of time and at the appropriate temperature to kill all pathogens. 4.    Store food at the proper temperature. 5.    Use safe water and safe raw materials. ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. This is a general derivative of ISO 9000. It is based on the PDCA Cycle. The ISO 22000 international standard specifies the requirements for a food safety management system that involves interactive communication, system management, prerequisite programs, and hazard analysis and critical control points principles (HACCP). If you need assistance in ISO 22000 or HACCP do not hesitate to contact us! #OLKON #FoodSafety #ISO22000

Regulatory Compliance and guidelines in the Biotechnology Industry Regulatory compliance in the biotechnology industry is crucial due to the high risks associated with biological materials, genetic modifications, and products that directly impact human health and the environment. Regulatory frameworks ensure that biotechnology companies meet rigorous safety, efficacy, and ethical standards. ⏹️ Regulatory compliance in biotechnology: 🔹Food and Drug Administration (FDA) - U.S. The FDA plays a critical role in regulating biotechnology products in the United States, particularly those involving human health, such as biopharmaceuticals, gene therapies, and diagnostics. 🔹 European Medicines Agency (EMA) - Europe In the European Union, the EMA oversees the approval of biotechnology products, especially those involving novel therapies and biologics. ⏹️ Guidelines in biotechnology industry: 🔹Good Manufacturing Practices (GMP) GMP regulations are essential for ensuring that biotech products are manufactured consistently and controlled according to quality standards. 🔹Good Clinical Practices (GCP) Ensuring that clinical trials are conducted ethically, with the rights and safety of participants protected. GCP compliance is necessary to ensure the integrity of clinical data submitted for regulatory approval. 🔹Good Laboratory Practices (GLP) GLP is particularly important for companies developing new drugs, as it ensures that laboratory results are valid and reproducible Even after a product is approved, regulatory bodies require ongoing compliance through post-market surveillance to monitor the long-term safety and effectiveness of biotech products.