Our Services

Helping medical device makers achieve trusted ISO 13485 certification.

Improved Product Quality & Patient Safety

The standard ensures strong quality control systems, leading to:

• Consistent and reliable products

• Reduced defects and recalls

• Enhanced patient safety and trust

Regulatory Compliance & Market Access

ISO 13485 helps your organization meet international regulatory requirements for medical devices. This makes it easier to:

• Enter global markets (EU, UK, Canada, etc.)

• Gain approvals from regulatory authorities

• Build credibility with clients and regulators

FAQs

What is ISO 13485?

An international standard for medical device quality management systems.

Why UKAS accreditation?

Who needs ISO 13485?

How long is certification valid?

How to start certification?

It ensures certification credibility and global acceptance.

Manufacturers, exporters, suppliers, and OEMs in the medical device industry require this certification.

Typically, ISO 13485 certification is valid for three years with annual surveillance audits.

Begin with a gap analysis followed by documentation and audits.

Thanks to the certification, our medical devices now meet global standards effortlessly.

Dr. Ali

The UKAS accreditation boosted our export opportunities and client trust significantly.

Ms. Khan

★★★★★

★★★★★

Contact Us

ACS Certifications (Pvt) Ltd

Plot No. 113, 4th Floor, T Block CCA,

Phase 8, DHA, Lahore, Pakistan

Tel: +92 300 9617101

Email: ejaz@qaicl.com

Customer Feedback: info@amtivo-pakistan.org ,

Complaints: info@amtivo-pakistan.org ,

Appeals: info@amtivo-pakistan.org ,

In association with: Amtivo Group (UK) — https://amtivo.com

Office hours: Monday to Saturday, 09:00 – 17:00 (Pakistan Standard Time)