Tailored regulatory architectures designed to mitigate risk and accelerate global market entry.
Turnkey strategies for startups and established firms entering the USA, EU, India, and GCC markets. We handle the roadmap from feasibility to final launch.
Aligning production facilities with GMP, ISO 9001, and ISO 13485 standards. We optimize your supply chain quality to meet international auditor expectations.
End-to-end lifecycle management for MDR, IVDR, and FDA 510(k). From clinical evaluation reports to post-market surveillance systems.
Navigating SFDA, FDA, and FSSAI regulations. We specialize in product labeling, ingredient review, and safety assessments for consumer goods.
Preparing your organization for SEDEX, SMETA, and SA8000 audits. Ensure transparency and ethical integrity across your entire global supply chain.
We act as your outsourced regulatory department. Managing certificate renewals, standard updates, and continuous internal audit readiness.
A systematic approach to global certification that eliminates uncertainty.
Market research and gap analysis to define the specific regulatory path for your unique product.
Drafting technical documentation, quality manuals, and risk management files tailored to target markets.
Internal auditing and mock-assessments to ensure your systems are robust enough for official scrutiny.
Final certification and ongoing representation (US Agent / EC Rep) to maintain market presence.
Our solutions are powered by over 20 years of audit experience. We don’t just solve compliance issues—we build resilient, world-class business systems.
Expert insights into international regulatory compliance and certification.
How long does it typically take to get ISO 13485 certified?
The timeline for ISO 13485 certification usually ranges from 4 to 9 months. This depends on the complexity of your manufacturing processes and the current state of your Quality Management System (QMS). Our gap analysis helps fast-track this by identifying immediate priorities.
What is the role of a US Agent for FDA registration?
Any foreign establishment engaged in the manufacture, preparation, or processing of a device imported into the USA must appoint a US Agent. We act as your official representative, facilitating communication between the FDA and your company, and assisting in scheduling inspections.
What is the difference between EU MDR and MDD?
The Medical Device Regulation (MDR 2017/745) replaced the old MDD. It is much more stringent, requiring enhanced clinical evaluation, stricter oversight of Notified Bodies, and more detailed post-market surveillance. We specialize in helping firms transition their technical files to the new MDR standards.
Do I need both CE Marking and UKCA for my products?
If you are selling in both the European Union and Great Britain, yes. While the requirements are currently similar, the UKCA is mandatory for the UK market, while CE Marking is required for the EU. We offer “Dual Compliance” packages to handle both simultaneously.
How can a subsidiary of QM Services India help my international firm?
As a subsidiary, QM Service Global leverages over 20 years of audit experience from the Indian market—one of the world’s largest manufacturing hubs. We provide a bridge for international companies to enter India (CDSCO/BIS) and for Indian manufacturers to go global.
What is a CDSCO MD-14 License?
The MD-14 is the Import License required by the Indian CDSCO for medical devices. We assist in the entire application process, including documentation, fee payment, and acting as your authorized Indian Agent to secure the license.
What products require BIS Certification in India?
BIS (Bureau of Indian Standards) is mandatory for a wide range of products including electronics, steel, chemicals, and toys. We help international manufacturers obtain FMCS (Foreign Manufacturers Certification Scheme) to legally sell in India.
Does QM Service Global provide EU Authorized Representative services?
Yes. For non-EU manufacturers, appointing an EU Authorized Representative (EC REP) is a legal requirement. We provide a legal address within the EU, maintain your technical documentation, and represent you before the European Competent Authorities.
What is involved in a SEDEX/SMETA audit?
A SMETA audit focuses on labor standards, health and safety, environment, and business ethics. Our consultants perform pre-audits and help you implement the necessary social accountability systems to pass the final audit with high marks.
How do I start the process for SFDA registration in Saudi Arabia?
The first step is a Product Classification. Once classified, we help you register your establishment on the GHAD system and submit the Medical Device Marketing Authorization (MDMA) applications. We handle the entire process from end to end.
Don’t see your question? Ask a Compliance Expert Directly
Whether it’s a Class III medical device or a complex chemical registration, our team is ready.