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Product Compliance: Challenges and solutions for companies in an ever-changing regulatory landscape of product conformity.

Product Compliance

Companies are obliged to comply with product-specific regulations. This obligation extends across various levels of legislation on the one hand and across several areas on the other. The number of product-specific requirements is constantly increasing and becoming ever more complex. Keeping pace is a major challenge for many manufacturers.

Mastering Product Compliance: Keeping Track in a Complex Regulatory Landscape

Due to the dynamic regulatory landscape, it is almost impossible to maintain an overview without a comprehensive compliance management system. The wide-ranging requirements concern aspects that affect every type of product – from product safety and product labelling to mandatory product certifications. In addition, the complexity increases due to the regulations of national laws in different markets, which vary from country to country.   

The growing complexity entails a range of obligations and, above all, a great deal of responsibility. Product safety is primarily in the hands of the manufacturer, as they are held accountable for non-compliance in the event of an accident and are subject to high penalties and considerable reputational damage. Sustained product compliance promises to keep products on the market in the long term and without sanctions. However, this requires early recognition and a comprehensive understanding of the numerous regulations to ensure seamless and long-lasting compliance.   

EFS Consulting Service Portfolio in the Context of Product Compliance  

EFS Consulting is focussed on supporting customers in the smooth market launch of their products and keeping them on the market without sanctions in the long term. Thanks to its customised solutions, EFS Consulting not only designs a compliant product, but also paves the way for successful and secure positioning on international markets.    

EFS Consulting provides support throughout the entire product life cycle: from researching product-specific requirements at a global level to recognising potential gaps at an early stage and providing support to close them. With many years of expertise, EFS Consulting supports clients not only with legal analyses but also with the implementation of individual requirements in order to reduce risks in the best possible way. By setting up Product Compliance Management Systems (PCMS), clients are empowered to ensure compliance not just once, but in the long term.  

  

The Following Areas of Product Compliance are Covered by EFS  

EFS Consulting’s holistic approach to evaluating and maintaining product compliance has already helped numerous companies successfully launch products in international markets. The key areas of expertise in Product Compliance include:

  1. Early warning system
  2. Regulatory analysis
  3. Market assessment
  4. Requirements Implementation 
  5. CE Compliance
  6. Troubleshooting 
  7. Product Compliance Management System (PCMS) 
  8. Product Compliance Training 

  

1. Early Warning System  

Through early warning systems and comprehensive legal research, EFS Consulting helps to ensure that products permanently comply with the relevant legal requirements. The team of experts continuously monitors new regulations and updates product-specific requirements so that customers are always up-to-date and can focus on their core business.   

The service minimises the risk of compliance issues while maximising efficiency in the export/import process.  

EFS Consulting Services:     

  • Set-up and operation of an early warning system
  • Identification of new / changed regulations worldwide
  • Basic analyzes / initial assessment
  • Creation of reports / newsletters
  • Global Regulation Tool

  

2. Regulatory Analysis  

Through extensive research and analyses, EFS Consulting supports companies in understanding and complying with complex and constantly changing regulatory requirements. Many years of expertise provide in-depth insights and practical recommendations to ensure that products comply with the relevant regulatory requirements.  

EFS Consulting Services:     

  • Regulatory overviews 
  • Detailed legal analysis / interpretation 
  • Product applicability check 
  • Clarification of specific issues with authorities / associations 
  • Recommendations for actions 
  • Legal comparisons 

  

3. Market Assessment  

A detailed conformity assessment of existing or newly developed products is carried out, taking into account applicable legal provisions, any shortcomings are identified at an early stage and strategic recommendations are made so that any gaps can be closed in good time and without sanctions. This enables companies to optimally prepare products for the market and proactively address potential risks.  

EFS Consulting Services:   

  • Identification of product compliance requirements (market entry check)
  • New product development support
  • Gap analysis of existing products
  • Compliance level assessment
  • Conformity systems guidance: CE, CCC, INMETRO, SNI, BSMI, NOM, KC, ISI, etc.

  

4. Requirements Implementation  

The implementation of legal requirements is crucial to ensure product compliance and fulfil legal requirements, protect consumers or similar and protect the reputation of companies. EFS Consulting offers customised solutions to ensure a smooth and efficient implementation.  

EFS Consulting Services:     

  • Implementation of regulations (procedural / organizational) 
  • Product documentation (e.g. user manual, DoC, etc.) 
  • Labels / product certification support  
  • Liaising with internal and external stakeholders 

  

5. CE Compliance 

The application of conformity labelling is a mandatory step before a product can be sold or put into operation on the EU market. From the verification of product conformity to the proper affixing of the CE marking, EFS Consulting accompanies you through every step of the entire conformity procedure.  

We ensure that all product-relevant EU regulations are complied with. In addition, support is provided in preparing the necessary technical documentation and issuing the EU Declaration of Conformity. This service ensures that products meet the highest safety and quality standards and can be placed on the European market without any problems.   

EFS Consulting Services:     

  • Identification of applicable EU laws and requirements 
  • Preparation of EU declarations of conformity and accompanying product documentation 
  • CE labelling support 
  • CE compliance workshops 

  

6. Troubleshooting  

Placing products on international markets often involves unforeseeable challenges. In an international market environment, effective support for existing problems is therefore essential. Effective risk minimisation is best achieved when problems are anticipated in advance.   

EFS Consulting’s experienced team of experts with extensive expertise quickly and efficiently resolves import issues, communication barriers and other unexpected situations to avoid potential negative impacts on manufacturers. The troubleshooting services provide companies with the necessary support to resolve queries from different markets and solve import issues.  

EFS Consulting Services:     

  • Clarification of inquiries from markets 
  • Support for import problems 
  • Central information hub for internal / external stakeholders 
  • Intermediary between parties 
  • Operations Center 

  

7. Product Compliance Management System (PCMS)  

In view of the constantly growing regulatory requirements and the need to maintain product compliance on a permanent basis, an effective Product Compliance Management System (PCMS) plays a crucial role for every company. PCMS services offer customised support in defining and implementing a comprehensive system.   

EFS Consulting Services:     

  • Conception of a PCMS 
  • Definition of roles & responsibilities 
  • Processes, organization & IT tools 
  • Product documentation management 
  • Strategies for ensuring lasting compliance in the organization 
  • Software tools 

  

8. Product Compliance Training  

Due to the variety of product-specific requirements, it is crucial for companies to develop and maintain a sound understanding of product compliance. EFS Consulting’s training programmes offer targeted training opportunities and workshops on product compliance aimed at raising awareness of applicable laws and regulations. Specialised lectures and tailor-made training courses support companies in equipping their employees with the necessary knowledge.   

EFS Consulting Services:     

  • Compliance awareness raising within organizations 
  • Product Compliance courses and workshops (Inhouse / Online) 
  • Expert talks 
  • Creation of training manuals 
  • Education roadmap 

 

Get in touch now to find customised solutions for product compliance and place your products on the market in the best possible way! 

Insights

What is product compliance and why is it a challenge for manufacturers?
When is a product compliant?
What is part of compliance?
What is the history of compliance?