STIG
attempts to bridge the gap and bring products and
services to your clinical practice and surgical room.
We provide ready made and customised services to fit your workflow
Get Started!We provide medical software
solutions which can fit into your workflow. The first
step would be to do a workflow analysis.
We provide services to develop
customised medical devices
We provide services to conduct
research into your next medical device or software
innovation
We can get your idea from
concept into a working prototype using plastic or even
metal fabrication facilities (inhouse)
ISO 13485 is the international standard that sets the requirements for a Quality Management System (QMS) specifically tailored to the medical device industry.
An ISO 13485 audit is carried out through a structured, multi-step process that evaluates a medical device company's Quality Management System (QMS) for compliance and effectiveness.
It is conducted internally and by our national external certification body (SIRIM), the audit follows core phases based on standard auditing principles.
An MDA Manufacturer License is an official establishment license issued by Malaysia's Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737), legally permitting an entity to manufacture medical devices within the country.
Under the MDA’s Single License Policy, holding a Manufacturer License allows us to both manufacture and distribute the specific medical devices that we produce.
Medical devices directly impact human lives. Having a license vetted by the Medical Device Authority gives healthcare providers, doctors, and private pharmacies immediate confidence in the safety, quality, and efficacy of our products.
Pioneer Status (PS) in Malaysia is fundamentally a strategic national endorsement governed by the Promotion of Investments Act 1986 to identify a company which is the first of its kind to provide such value to the national ecosystem
The Promotion of Investments Act 1986 (Act 327) is a foundational Malaysian statute designed to stimulate the establishment and development of industrial, agricultural, and other commercial enterprises, as well as to encourage exports.
A clinical trial under the Good Clinical Practice (GCP) in Malaysia is a research study involving human participants designed to test the safety, efficacy, and quality of medical treatments or investigational products, strictly following the Malaysian Guideline for Good Clinical Practice.
In Malaysia, the primary regulatory agency in charge of clinical trials and Good Clinical Practice (GCP) oversight is the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health.
We are dedicated to driving sustainable growth, fostering social responsibility, and maintaining the highest standards of corporate governance.
Minimizing our carbon footprint through renewable energy adoption, waste reduction protocols, and sustainable resource management across all operations.
Cultivating an inclusive, safe corporate culture while actively investing in local communities and safeguarding human rights throughout our supply chain.
Upholding ethics, data privacy transparency, and stakeholder alignment through accountable board leadership and strict regulatory compliance policies.
Ready to start your next project with us?
Looking for a job?
Investor relations? Yes, we are open for discussion.
Our valued Supplier / Vendor / Existing Clients ?
Respected ISO and Finance Auditors ?
Give us a call or send us an email and we will
get back to you as soon as possible!