About ISO 9001:2015 is a business standard for improving operations and quality while reducing costs. This is accomplished by implementing business processes that meet a set of good business requirements outlined within the standard. What it means for your business For businesses, certification to ISO 9001 demonstrates a commitment to quality products and services. Certification opens the doors to many new avenues and customers worldwide. Benefits of certification Companies that implement the requirements of ISO 9001:2015 and achieve certification commonly find benefits such as: • Increased business efficiency, Higher levels of customer satisfaction & New customer opportunities • Lower unnecessary costs • More reliable quality of processes and products • ISO 9001 is widely used as a supply-chain requirement, and the number of industries that recognize the value of ISO 9001 as a purchasing criteria continues to grow.
About ISO 13485 is a stand-alone QMS standard derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical devices manufacturing environment. What it means for your business Having ISO 13485 shows an established and maintained effectiveness of your process, while ensuring the consistent design, development, production, installation and delivery of medical devices that are safe for their intended purposes. Benefits of certification Companies that implement the requirements of ISO 13485:2016 and certification commonly find benefits such as meeting legal, regulatory, contractual and marketing requirements for proved product safety. Although not fully harmonized, an ISO 13485 Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) standards.
About ISO 15378 is an important, internationally valid standard for manufacturers of pharmaceutical packaging that comes into direct contact with medicinal products. With ISO 15378 certification, you can demonstrate that your products meet high international standards for pharmaceutical packaging. What it means for your business ISO 15378 is a critical standard for businesses involved in the production of primary packaging materials for medicinal products. It promotes quality, safety, and regulatory compliance, which are essential in the highly regulated pharmaceutical and healthcare industries. Compliance with this standard can improve your business's reputation, reduce risks, and potentially lead to cost savings over time. Benefits of certification The ISO 15378 standard enables you to comply with legal requirements for pharmaceutical and medical device primary packaging materials. ISO 15378 integrates the requirements of ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as Code of Federal regulations (U.S.), European directives and Indian regulations. Adhering to GMP principles boosts the efficiency of your production processes. The standard also helps to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life.
About cGMP refers to the current Good Manufacturing Practice regulations enforced by the FDA. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. What it means for your business Medical Devices produced by GMP-certified growers gives customers peace of mind when making their purchase. Without it, sales can suffer, since sensitive customers want to know they are buying safe, quality products. Benefits of certification Companies that implement GMP commonly find benefits such as: • Demonstrating an organization’s management capabilities in product quality and safety assurance • Enabling employees to develop good production/operational habits • Reducing safety risk • Timely detection of production and management problems, reducing costs • Better understanding of and compliance with relevant laws and regulations • Enhanced international credibility and public image
About cGMP refers to the current Good Manufacturing Practice regulations enforced by the FDA. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. What it means for your business Medical Devices produced by GMP-certified growers gives customers peace of mind when making their purchase. Without it, sales can suffer, since sensitive customers want to know they are buying safe, quality products. Benefits of certification Companies that implement GMP commonly find benefits such as: • Demonstrating an organization’s management capabilities in product quality and safety assurance • Enabling employees to develop good production/operational habits • Reducing safety risk • Timely detection of production and management problems, reducing costs • Better understanding of and compliance with relevant laws and regulations • Enhanced international credibility and public imag
Role of the EU Authorized Representative (EC-REP) Foreign manufacturers must appoint an EU Authorized Representative (AR) before they can sell their medical devices and IVDs in Europe. What are the responsibilities of the EU AR? In addition to acting as a liaison with the European national Competent Authorities, the EU AR is responsible for verify the technical documentations, regulatory compliance, Declaration, Labeling etc. before market and during Product Lifetime maintain a copy of the technical documentation and CE certificate, Provide a current copy of your Technical File or EU Declaration of Conformity to Competent Authorities up on request& inform Manufacturer about complaint. Benefits of EC REP The EU AR acts as the manufacturer’s regulatory representative in the European Single Market and is the point of contact between the manufacturer and the European national Competent Authorities. The EU AR is also referred to as an EAR, EC Representative, EC Rep or Authorized Representative. The MDR/IVDR increased the responsibilities of the EU AR. One significant change is that the AR now explicitly shares liability with the manufacturer for products on the market.
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