{"id":2896,"date":"2024-10-15T13:23:36","date_gmt":"2024-10-15T11:23:36","guid":{"rendered":"https:\/\/www.accomplie.com\/product-compliance\/"},"modified":"2024-10-28T10:17:00","modified_gmt":"2024-10-28T09:17:00","slug":"product-compliance","status":"publish","type":"page","link":"https:\/\/www.accomplie.com\/en\/product-compliance\/","title":{"rendered":"Product Compliance"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background hundred-percent-fullwidth non-hundred-percent-height-scrolling fusion-no-medium-visibility fusion-no-large-visibility\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column expertise-mobile-bg-picture\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-image:url(&#039;https:\/\/www.accomplie.com\/wp-content\/uploads\/2024\/01\/popup-mobile-1.jpg&#039;);--awb-bg-position:center center;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0;--awb-spacing-left-medium:0;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-motion-effects=\"[{&quot;type&quot;:&quot;&quot;,&quot;scroll_type&quot;:&quot;transition&quot;,&quot;scroll_direction&quot;:&quot;up&quot;,&quot;transition_speed&quot;:&quot;1&quot;,&quot;fade_type&quot;:&quot;in&quot;,&quot;scale_type&quot;:&quot;up&quot;,&quot;initial_scale&quot;:&quot;1&quot;,&quot;max_scale&quot;:&quot;1.5&quot;,&quot;min_scale&quot;:&quot;0.5&quot;,&quot;initial_rotate&quot;:&quot;0&quot;,&quot;end_rotate&quot;:&quot;30&quot;,&quot;initial_blur&quot;:&quot;0&quot;,&quot;end_blur&quot;:&quot;3&quot;,&quot;start_element&quot;:&quot;top&quot;,&quot;start_viewport&quot;:&quot;bottom&quot;,&quot;end_element&quot;:&quot;bottom&quot;,&quot;end_viewport&quot;:&quot;top&quot;,&quot;mouse_effect&quot;:&quot;track&quot;,&quot;mouse_effect_direction&quot;:&quot;opposite&quot;,&quot;mouse_effect_speed&quot;:&quot;2&quot;,&quot;infinite_animation&quot;:&quot;float&quot;,&quot;infinite_animation_speed&quot;:&quot;2&quot;}]\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-empty-column-bg-image fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.accomplie.com\/wp-content\/uploads\/2024\/01\/popup-mobile-1.jpg\"><img decoding=\"async\" class=\"fusion-empty-dims-img-placeholder\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271040%27%20height%3D%27200%27%20viewBox%3D%270%200%201040%20200%27%3E%3Crect%20width%3D%271040%27%20height%3D%27200%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\"><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-margin-bottom:40px;--awb-min-height:90vh;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-align-content-center fusion-flex-content-wrap\" style=\"width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_3 1_3 fusion-flex-column fusion-flex-align-self-flex-start\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-image:url(&#039;https:\/\/www.accomplie.com\/wp-content\/uploads\/2024\/01\/popup-n3.jpg&#039;);--awb-bg-position:center center;--awb-bg-size:cover;--awb-width-large:33.333333333333%;--awb-margin-top-large:0px;--awb-spacing-right-large:0;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0;--awb-width-medium:33.333333333333%;--awb-order-medium:0;--awb-spacing-right-medium:0;--awb-spacing-left-medium:0;--awb-width-small:100%;--awb-order-small:2;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" 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data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column fusion-empty-column-bg-image fusion-column-has-bg-image\" data-bg-url=\"https:\/\/www.accomplie.com\/wp-content\/uploads\/2024\/01\/popup-n3.jpg\"><img decoding=\"async\" class=\"fusion-empty-dims-img-placeholder\" src=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271040%27%20height%3D%271400%27%20viewBox%3D%270%200%201040%201400%27%3E%3Crect%20width%3D%271040%27%20height%3D%271400%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\"><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_2_3 2_3 fusion-flex-column fusion-flex-align-self-center expertise-unterseite-text-box\" style=\"--awb-padding-top:0px;--awb-bg-size:cover;--awb-width-large:66.666666666667%;--awb-margin-top-large:0px;--awb-spacing-right-large:80px;--awb-margin-bottom-large:20px;--awb-spacing-left-large:80px;--awb-width-medium:66.666666666667%;--awb-order-medium:0;--awb-spacing-right-medium:80px;--awb-spacing-left-medium:80px;--awb-width-small:100%;--awb-order-small:1;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\" data-motion-effects=\"[{&quot;type&quot;:&quot;&quot;,&quot;scroll_type&quot;:&quot;transition&quot;,&quot;scroll_direction&quot;:&quot;up&quot;,&quot;transition_speed&quot;:&quot;1&quot;,&quot;fade_type&quot;:&quot;in&quot;,&quot;scale_type&quot;:&quot;up&quot;,&quot;initial_scale&quot;:&quot;1&quot;,&quot;max_scale&quot;:&quot;1.5&quot;,&quot;min_scale&quot;:&quot;0.5&quot;,&quot;initial_rotate&quot;:&quot;0&quot;,&quot;end_rotate&quot;:&quot;30&quot;,&quot;initial_blur&quot;:&quot;0&quot;,&quot;end_blur&quot;:&quot;3&quot;,&quot;start_element&quot;:&quot;top&quot;,&quot;start_viewport&quot;:&quot;bottom&quot;,&quot;end_element&quot;:&quot;bottom&quot;,&quot;end_viewport&quot;:&quot;top&quot;,&quot;mouse_effect&quot;:&quot;track&quot;,&quot;mouse_effect_direction&quot;:&quot;opposite&quot;,&quot;mouse_effect_speed&quot;:&quot;2&quot;,&quot;infinite_animation&quot;:&quot;float&quot;,&quot;infinite_animation_speed&quot;:&quot;2&quot;}]\" data-scroll-devices=\"small-visibility,medium-visibility,large-visibility\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-center fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\" style=\"--awb-text-color:var(--awb-custom_color_4);--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-font-size:48px;\"><h1 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;font-size:1em;line-height:1.2;\"><h1><strong>Product Compliance: Important Aspects of Compliance with Legal Requirements<\/strong><\/h1><\/h1><\/div><div class=\"fusion-text fusion-text-1 fusion-text-no-margin\" style=\"--awb-font-size:20px;--awb-line-height:1.5em;--awb-text-color:var(--awb-custom_color_4);--awb-margin-top:20px;--awb-margin-bottom:20px;\"><p><b>Product compliance<\/b> plays a central role in the global economy. Companies must ensure that their products comply with the applicable legal and regulatory requirements. A lack of product compliance can lead to significant legal consequences and financial losses. To prevent these risks, many companies rely on the expertise of a product compliance lawyer. This ensures that products meet the respective regulations both nationally and internationally.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-custom_color_6);--awb-margin-top:50px;--awb-margin-bottom:0px;--awb-font-size:24px;\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;font-size:1em;line-height:1.1;\"><h2><strong>Core elements of a product compliance system<\/strong><\/h2><\/h2><\/div><div class=\"fusion-text fusion-text-2 fusion-text-no-margin\" style=\"--awb-font-size:20px;--awb-line-height:1.5em;--awb-text-color:var(--awb-custom_color_4);--awb-margin-top:20px;--awb-margin-bottom:20px;\"><p>An effective Product Compliance Management System (PCMS) is based on several central elements that should integrate every system, regardless of the specific company structure.<\/p>\n<ol>\n<li><b>Corporate culture: <\/b>The culture in the company significantly influences the effectiveness of the PCMS. Important aspects are corporate values that shape legal and regulatory behaviour, as well as an open error culture. To this end, clear codes of conduct should be implemented and binding communication in the supply chain should be promoted.<\/li>\n<li><b>Objectives: <\/b>It is important to define clear, measurable objectives for the PCMS and to regularly review and adjust them. The main objective is to comply with all regulatory requirements throughout the entire product life cycle. This includes all stages from development and production to distribution and decommissioning.<\/li>\n<li><b>Risk management: <\/b>A robust risk management system continuously identifies and assesses product compliance risks. The aim here is to identify potential violations at an early stage so that structured measures can be developed to minimise the risks. Regularly monitor the effectiveness of these measures.<\/li>\n<li><b>Programme: <\/b>The PCMS programme encompasses all actions and processes necessary to ensure product compliance. Integrate these into your existing processes and adapt them as needed, particularly in risk management, quality management and compliance.<\/li>\n<li><b>Organisation: <\/b>Clear organisational measures are required to effectively implement the PCMS. Define relevant roles and responsibilities and ensure that employees receive appropriate training so that they can efficiently fulfil their product compliance tasks.<\/li>\n<li><b>Communication and training: <\/b>Internal and external partners must be informed about the importance of product compliance. Training measures should raise employees&#8217; awareness and help them understand the importance of complying with binding obligations.<\/li>\n<li><b>Monitoring and improvement: <\/b>Monitor the PCMS regularly and risk-based to verify its effectiveness. Use existing control structures and document deviations. Implement clear corrective and improvement measures to address any deficiencies identified.<\/li>\n<\/ol>\n<p>A well-implemented PCMS not only protects against legal risks, but can also be used as a strategic advantage to successfully meet market challenges.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-3 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-custom_color_6);--awb-margin-top:50px;--awb-margin-bottom:0px;--awb-font-size:24px;\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;font-size:1em;line-height:1.1;\"><h2><strong>Why you need a product compliance lawyer<\/strong><\/h2><\/h2><\/div><div class=\"fusion-text fusion-text-3 fusion-text-no-margin\" style=\"--awb-font-size:20px;--awb-line-height:1.5em;--awb-text-color:var(--awb-custom_color_4);--awb-margin-top:20px;--awb-margin-bottom:20px;\"><p>A <b>product compliance lawyer<\/b> is the right point of contact when it comes to understanding and implementing the legal framework. He helps companies to comply with the regulations in different markets to ensure that their products can be distributed without problems. Especially in the area of international markets, product compliance is a challenge because different countries have different requirements. An experienced product compliance lawyer knows the relevant laws and standards and helps to minimise liability risks and ensure market access.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-4 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-custom_color_6);--awb-margin-top:50px;--awb-margin-bottom:0px;--awb-font-size:24px;\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;font-size:1em;line-height:1.1;\"><h2><strong>The tasks of a product compliance lawyer<\/strong><\/h2><\/h2><\/div><div class=\"fusion-text fusion-text-4 fusion-text-no-margin\" style=\"--awb-font-size:20px;--awb-line-height:1.5em;--awb-text-color:var(--awb-custom_color_4);--awb-margin-top:20px;--awb-margin-bottom:20px;\"><p>A <b>product compliance lawyer<\/b> performs a wide range of tasks that are essential for compliance with legal requirements, such as:<\/p>\n<ol>\n<li><b>Analysing product requirements<\/b>: A lawyer checks which specific directives and standards apply to the respective product.<\/li>\n<li><b>Risk assessment<\/b>: Identifying potential liability risks associated with the production and distribution of products.<\/li>\n<li><b>Documentation and certification<\/b>: Assisting with the preparation of necessary documents and certificates for the international market.<\/li>\n<li><b>Design and implementation of a PCMS: <\/b>As part of <a href=\"https:\/\/www.accomplie.com\/en\/compliance-services\/\">compliance advice<\/a>, the lawyer helps to set up a compliance management system to ensure that legal requirements are met on an ongoing basis.<\/li>\n<li><b>Audits and internal investigations: <\/b>Audits are conducted regularly to ensure compliance with all regulations. Internal investigations, on the other hand, are conducted on an ad hoc basis and are carried out when there is suspicion of rule violations or compliance violations.<\/li>\n<\/ol>\n<p>Comprehensive <b>product compliance<\/b> is not only a legal requirement, but also a competitive advantage. By enlisting the expertise of a <b>product compliance lawyer<\/b>, companies can ensure that their products are brought to market in compliance with the rules, thus avoiding expensive litigation.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-5 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-custom_color_6);--awb-margin-top:50px;--awb-margin-bottom:0px;--awb-font-size:24px;\"><h2 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;font-size:1em;line-height:1.1;\"><h2><strong>Challenges for a product compliance lawyer<\/strong><\/h2><\/h2><\/div><div class=\"fusion-text fusion-text-5 fusion-text-no-margin\" style=\"--awb-font-size:20px;--awb-line-height:1.5em;--awb-text-color:var(--awb-custom_color_4);--awb-margin-top:20px;--awb-margin-bottom:20px;\"><p>An experienced product compliance lawyer faces a variety of challenges. A key challenge is identifying and implementing the specific requirements in the PCMS. This also includes creating and managing the relevant documentation for senior management.<\/p>\n<p>The lawyer must ensure that all material legal issues are addressed to reliably ensure product compliance. This includes, in particular, a legal review of product development and manufacturing processes.<\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" target=\"_self\" title=\"Consult a product compliance lawyer now\" aria-label=\"Consult a product compliance lawyer now\" href=\"\/kontakt\/\"><span class=\"fusion-button-text\">Consult a product compliance lawyer now<\/span><\/a><\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-2 fusion-button-default-span fusion-button-default-type accomplie-button-link-1\" 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