Penang, Malaysia

Simplify to Amplify,
Simplify without Compromise

A training and consultancy firm helping organizations build robust, practical quality and regulatory systems.

Official Accreditation

HRDCorp Approved Training Provider

Certified partner for claimable, industry-focused programs.

17+

Training Modules

ISO, MDR, FDA QSR, validation, risk & quality tools.

100%

HRDCorp Claimable

Every training program is fully claimable under HRDCorp.

Consultancy Pillars

QMS, audit, compliance, corrective action, technical support.

About Us

Clarity in compliance.
Confidence in quality.

Cogence Consulting is a training and consultancy firm founded in 2025, dedicated to helping organizations build robust, practical, and sustainable quality and regulatory systems.

We specialize in quality management systems, regulatory compliance, and risk-based approaches for regulated industries, with a strong focus on medical devices as well as the others. Our services are designed not just to meet standards and regulations, but to make them work effectively within real-world operations.

At Cogence Consulting, we believe that compliance should be clear, practical, and value-adding. We bridge the gap between regulatory requirements and day-to-day implementation by translating complex standards into actionable guidance, hands-on training, and fit-for-purpose solutions.

Founded 2025 HRDCorp Approved Penang, Malaysia

Our Vision

Vision

Clarity in compliance. Confidence in quality.

Our Mission

Mission

To provide practical training and consultancy that translates complex standards and regulations into effective, real-world solutions for our clients.

Core Values

The principles that
shape our work.

Four guiding values that show up in every engagement, from a single workshop to a multi-month QMS build.

Simplifying complex processes while maintaining high quality

We are committed to simplifying complex processes into clear, actionable solutions for our clients, ensuring ease of implementation while maintaining the highest standards of quality.

Empowering knowledge to drive long-term success

We are dedicated to delivering a personalized, engaging, and flexible learning experience that optimizes knowledge retention and effectiveness through continuous feedback and the promotion of practical application for sustained success.

Focused on excellence, providing the highest quality work

We are committed to excellence in every project, consistently delivering top-quality work to provide our clients with exceptional value.

Fostering partnerships to drive greater success

We view our relationships with clients and industry partners as true collaborations, working together towards shared goals to achieve greater success.

Our Services

Training & consultancy
built for regulated industries.

From ISO 13485 to FDA QMSR, from gap assessments to corrective action, delivering programs that translate compliance into capability.

Industry-focused modules, delivered in workshop format

ISO 13485 Quality Management System Requirements for Medical Devices
ISO 13485 Internal Auditing
ISO 14971 Risk Management for Medical Devices
ISO 14644 Cleanroom and Associated Controlled Environment
Medical Device Manufacturing Process Validation
Medical Device Single Audit Program (MDSAP)
EU Medical Device Regulation (EU MDR 2017/745)
Understanding the US FDA QMSR Requirements
FDA 21 CFR Part 820 Awareness for the Member of Management
Introduction to Medical Device Manufacturing
Eight Disciplines of Problem Solving (8D)
The New 7 QC Tools
FMEA for the Medical Device Industry
Principles of Software Validation
Root Cause Analysis
8D Problem Solving Process
ISO 9001:2015 Quality Management System Requirements
ISO 9001:2015 Internal Auditing Training

The list of training programs above is non-exhaustive. All programs are HRDCorp claimable

Tailored engagements, from gap assessment to full QMS build

Quality Management System development & improvement
Internal Audit support
Management System & Regulatory Compliance Gap Assessment
Corrective Action support
Technical activities support such as development of risk management, and process validation activities

The list of consultancy services above is non-exhaustive. At Cogence Consulting, we tailor our services to meet our clients' needs.

Why Cogence?

Cogent: (of an argument or case) clear, logical, and convincing. The same standard we apply to every quality system, audit, and training program we deliver.

How we work with you

From classroom to audit room to shop floor

Three lenses: training, compliance, and hands-on implementation, so standards translate into lasting capability.

01: Training

Build capability your teams keep

HRDCorp-claimable workshops on ISO 13485, MDR, FDA QMSR, validation, and quality tools, designed for retention and real application.

02: Compliance

See gaps before regulators do

Gap assessments, internal audit support, and corrective-action guidance aligned to your QMS and the standards that matter to your market.

Quality implementation on operations floor

03: Implementation

Make the system work in operations

Technical support for risk management, process validation, and QMS improvement, so documentation becomes behaviour on the floor.

Let's start a conversation.

Reach out about a training program, a consultancy engagement, or just to ask a question.

Phone

+6011 - 2627 3638

Email

[email protected]

Address

Settlements Workspace, VO-043,
170-08, Livingston Tower,
Argyll Road, 10050 George Town,
Penang, Malaysia