We provide comprehensive onsite and online consulting services for ISO 13485:2016 certification. Our clients benefit not only from our expertise during the initial certification process but also from ongoing post-certification consulting. This ensures continual enhancement of their business processes and the standardization of their process and quality initiatives with added value from our consultants.
We offer comprehensive consulting services for ISO 13485:2016 certification, covering various aspects such as conducting an awareness quality policy and objectives workshop, performing gap analysis, and designing all necessary documentation including manuals, procedures, work instructions, and formats. Our goal is to ensure a 100% successful ISO 13485 certification audit within the agreed project completion timeframe.
ISO 13485:2016 , crafted by the International Organization for Standardization (ISO), is a globally recognized standard designed exclusively for organizations engaged in the design, development, production, installation, and servicing of medical devices and associated services. It furnishes medical device manufacturers with a structured framework to establish and uphold a robust quality management system, ensuring the safety and effectiveness of medical devices.
Regulatory Compliance: ISO 13485:2016 certification ensures adherence to industry-specific regulatory requirements, enabling organizations to fulfill legal obligations and obtain product approval across diverse markets.
Market Access: ISO 13485 certification is frequently required by regulatory bodies, customers, and stakeholders when acquiring medical devices, streamlining market entry processes and creating opportunities for business expansion.
Competitive Advantage: ISO 13485 certification distinguishes organizations by highlighting their dedication to quality, safety, and regulatory compliance, strengthening their reputation and competitiveness within the market.
At Legal Way Startup we uphold a partnership-oriented approach to certification services. Central to our ethos is the cultivation and nurturing of positive and supportive relationships with our clients. We seamlessly blend the capabilities and resources of a large Certification Body with the personalized attention and encouragement typically associated with smaller entities.
Transparency is paramount in our pricing structure. We believe in providing our clients with clear and upfront information, ensuring there are no hidden extra costs. Our quotes offer prospective clients a detailed breakdown of the services they will receive, empowering them to make informed decisions with confidence
Legal Way Startup can expedite the certification process, reducing the timeframe to a minimum of days for completion.
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When pursuing an ISO Certification, every business must provide the following documentation:
Verification of the business's registration can be established through:
