ISO 13485 & GDPMD: Medical Device Compliance
Safeguarding medical devices, ensuring safety at every stage.
HRD Corp registered training provider · Consultants and trainers with 10+ years of industry experience
- ISO 13485 & GDPMD gap assessment
- Documentation and implementation
- Internal audit and audit readiness
Request a quote
Tell us about your organisation. A consultant replies within one business day.
Your request for a ISO 13485 & GDPMD quote is in. A Connext consultant will come back to you within one business day. If it is urgent, WhatsApp us on +60 12-668 9110.
WhatsApp usWhat is ISO 13485 & GDPMD?
ISO 13485 establishes requirements for a comprehensive quality management system covering all stages of the medical device lifecycle from design to distribution. It ensures manufacturers and suppliers adhere to international standards, effectively manage risks, and continuously improve processes.
GDPMD provides guidelines for the proper storage, transportation, and handling of medical devices during distribution, ensuring their integrity and effectiveness are maintained throughout the supply chain, safeguarding patient safety and regulatory compliance.
ISO 13485 vs GDPMD: which do you need?
For manufacturers and suppliers at all stages of production.
- Manufacturers
- Suppliers
What it coversDesign controls, risk management, production processes, post-market surveillance
For Authorized Representatives, distributors and importers.
- Authorized Representatives
- Distributors
- Importers
What it coversMaintaining device safety during storage, transport and distribution
Our ISO 13485 & GDPMD services.
We tailor every engagement to your industry, size and risk profile. No generic templates.
ISO 13485 & GDPMD training
HRD Corp claimable training so the system is maintained in-house after we leave, not rented from a consultant.
Leave the heavy lifting to us.
On your floor, with your team. We map what exists against what the standard needs.
Documentation and controls designed into daily operations, right-sized for your business.
HRD Corp claimable training so the system is owned in-house, not by consultants.
We prepare you for both stages and stay through audit day.
Industries we work with
Trusted by Malaysian manufacturers and enterprises
Why choose Connext for ISO 13485 & GDPMD.
Your ISO 13485 & GDPMD questions answered.
Who needs ISO 13485?
Medical device manufacturers, suppliers, and service providers at all stages of production: design, manufacturing, packaging, labelling, storage, installation, and servicing.
Who needs GDPMD?
Authorized representatives (AR), distributors, importers, and anyone involved in moving medical devices from manufacturer to user, including warehousing, transportation, and logistics.
Why is GDPMD certification important?
Under the Medical Device Regulations 2012, manufacturers require ISO 13485 certification while local Authorized Representatives, importers and distributors require GDPMD certification before applying for their Establishment License.
How long is the process?
Most organizations achieve certification within 3 to 6 months with proper planning, depending on size and complexity.
Unsure about choosing the right certification body?
We partner with both international and local bodies like SGS, BSI, LRQA and BV to ensure a smooth certification process.
Do you offer a maintenance package for subsequent years?
Yes. Our maintenance packages are tailored to your needs: Internal Audit Assistance, Non-Conformance Support, and Document and Process Improvement.
Begin a conversation with our consultants.
Outline your requirements and our team will come back to you within one business day with a clear next step.