QMS/ISO Certification Support

At Registitute, we specialize in helping organizations across the healthcare, pharmaceutical, and cosmeceutical sectors achieve and maintain ISO-compliant Quality Management Systems (QMS). Whether you’re a medical device manufacturer, distributor, or importer operatingour QMS ISO certification support ensures that your systems are fully aligned with regulatory expectations and global standards.

Comprehensive ISO Certification and QMS Services

Our expert team delivers end-to-end QMS support, including:

Gap Analysis & System Evaluation: We assess your current QMS to identify gaps against ISO 13485, ISO 9001, and other relevant standards.
QMS Establishment from Scratch: For startups or new product lines, we build your entire QMS framework tailored to your regulatory path.
Audit Support (Internal & External): Prepare for audits confidently with our remote and on-site support for both internal and third-party audits.
Digital Transformation into eQMS: Upgrade from manual QMS to electronic QMS (eQMS) to improve data accuracy, traceability, and performance tracking.

We understand that each organization is unique—our support is customized to your needs and industry requirements.

We provide tailored QMS ISO certification support across regulated sectors, including:

Medical Devices & IVDs: ISO 13485/9001 implementation for manufacturers, distributors, importers, and authorized representatives.
Pharmaceuticals: QMS systems aligned with Good Manufacturing Practice (GMP) standards.
Cosmeceuticals: Support for ISO 22716 compliance.
Food Supplements: Compliance with EU GMP standards (EC No 2002/2006).
Safety and Essential Performance Standards for Medical Electrical Equipment (IEC 62366).

If your certification goals target specific procedures or standards, we also provide niche expertise in:

  • Risk Management – ISO 14971

  • Clinical Evaluation & Investigation – ISO 14155 / ICH GCP

  • Software Lifecycle Processes – IEC 62304

  • Usability Engineering – IEC 62366

  • Electrical Safety & Performance – IEC 60601 standards

Benefits of Our QMS Support Services

  • ISO 13485 & ISO 9001 Certification Readiness

  • Expert-led Audits & Training

  • Seamless QMS Digitalization (eQMS)

  • Regulatory Compliance with SFDA & Global Bodies

  • Reduced Time to Certification

  • Scalable Solutions for SMEs & Enterprises

Partner with Registitute for QMS Success

With years of experience in regulatory consultancy and medical compliance, Registitute is a trusted partner for businesses seeking QMS ISO certification. Whether you’re aiming for ISO 13485 certification for medical devices or GMP compliance for pharmaceuticals, we’re here to streamline your journey.

Contact us today to discuss your compliance objectives, audit timelines, or digital transformation needs. Our consultants are ready to support your success.

X