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Quality & Compliance

Our Certifications

We take pride in being a certified and globally recognized manufacturer of Surgical, Dental, Veterinary, and Beauty Instruments.

7+
International Certifications
63+
Years of Excellence
50+
Countries Served
100%
Quality Compliance

ISO 9001:2015

Globally recognized certification for quality and compliance

CE Marking

Globally recognized certification for quality and compliance

FDA Registration

Globally recognized certification for quality and compliance

PSQCA Approved

Globally recognized certification for quality and compliance

WHO Compliant

Globally recognized certification for quality and compliance

SMEDA Member

Globally recognized certification for quality and compliance

SECP Registered

Globally recognized certification for quality and compliance

Detailed Information

Certification Details

Learn more about our key certifications and what they mean for our customers.

ISO 9001:2015

Full Name: ISO 9001:2015 Quality Management System

Certified Since: 2005

Expiry Date: 2026

Certifying Body: TÜV SÜD

Scope: Design, Development, Manufacturing and Export of Surgical, Dental, Veterinary and Beauty Instruments

CE Marked

Full Name: CE Marking (Conformité Européenne)

Certified Since: 2008

Expiry Date: 2026

Certifying Body: Notified Body 0123

Scope: All medical devices Class I, IIa, IIb as per EU MDR 2017/745

FDA Compliant

Full Name: FDA Registration and Compliance

Certified Since: 2010

Expiry Date: 2026

Certifying Body: U.S. Food and Drug Administration

Scope: Medical device establishment registration and product listing

WHO-GMP

Full Name: WHO Good Manufacturing Practices

Certified Since: 2012

Expiry Date: 2026

Certifying Body: World Health Organization

Scope: Manufacturing practices for medical devices and surgical instruments

ISO 13485

Full Name: ISO 13485 Medical Devices Quality Management

Certified Since: 2015

Expiry Date: 2026

Certifying Body: BSI Group

Scope: Quality management systems for medical device manufacturing

For detailed information about SMEDA, SECP, and other registrations, please contact our compliance department.

Why It Matters

Why Certifications Matter

At Surgicrafts, we believe that certifications are not just badges—they are a testament to our commitment to quality, safety, and excellence. Our certifications ensure that every instrument we manufacture meets the highest international standards.

Patient Safety

Certified instruments ensure maximum safety for patients during surgical procedures.

Global Compliance

Our certifications allow us to export to over 50 countries worldwide.

Quality Assurance

Regular audits ensure consistent quality across all our manufacturing processes.

Customer Trust

Certifications build confidence and trust with our global customer base.

Quality Control
ISO Certified
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