ADHOCON has announced its now a Contract Legal Manufacturer (CLM) service for Software as a Medical Device (SaMD) and artificial intelligence (AI) in healthcare after receiving ISO 13485 certification.
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SaMD / digital health
The company provides end-to-end compliance with international regulations for its clients, providing services in the design, development, manufacturing, distribution, and support of SaMD and AI.
As the legal manufacturer for its clients, ADHOCON takes full responsibility for all aspects of product registration, compliance, post-market surveillance, and even insurance.
From ISO 13485 over US FDA 21CFR820 to EU MDR and beyond, ADHOCON handles all regulatory hurdles, including cybersecurity, GDPR and clinical requirements.
The company offers a constant monthly fee structure, providing clients with predictable budgeting for their quality and regulatory needs. As partners in innovation, ADHOCON scales with its clients, adapting to each company's evolving requirements to ensure a compliant and swift global market presence.
ADHOCON specialises in serving healthcare companies and start-ups with AI and software solutions but require a robust Quality Management System (QMS) and regulatory expertise to navigate the global market.
Rudolf Wagner, founder and CEO of ADHOCON, said: "Our mission is to enable our clients to focus on their core competencies of innovation and development, while we handle the intricate regulatory requirements and quality assurances that come with global market access. With over 50 years of combined experience in the industry and more than 200,000 products successfully registered worldwide, we are equipped to propel healthcare advancements to the forefront where they belong."
