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Product Certification is the process of verifying that a specific product has passed performance and quality assurance tests and meets the qualification criteria defined in regulations, standards, or contracts.
The CE Marking serves as the essential conformity mark which products must obtain to be sold throughout the European Economic Area (EEA). The healthcare industry operates under two primary regulations which govern its practices: MDR (2017/745) and IVDR (2017/746).
The CE mark can be obtained by manufacturers who need to complete these procedures according to both regulations:
It is a formal process used to prove that a piece of equipment meets the essential health and safety requirements (EHSRs) of the European Union.
While people often call it “certification,” it is technically a CE Marking process. For most machines, the manufacturer “self-certifies” by creating a technical file and signing a legal document. However, for high-risk machines, a third-party audit is mandatory.
We are currently in a transition period between two sets of laws:
The present law stands until January 19 2027 according to Directive 2006/42/EC which serves as the Machinery Directive. The new law which replaces the directive exists as Regulation EU 2023 1230 Machinery Regulation. The regulation exists as “in force” yet its requirements will not become obligatory until January 20 2027.
You need this “certification” if you manufacture or import:
1. Machinery: An assembly contains at least one operational component which requires energy for its functionality instead of relying on human power.
2. Safety Components: The system includes safety elements which consist of light curtains and emergency stop buttons.
3. Lifting Accessories: The group includes chains and ropes and slings as lifting accessories.
4. Partly Completed Machinery: The system consists of units which require robotic arm components to operate but will be integrated into a more extensive system.
A medical device is subject to the Machinery Directive if it meets two criteria:
The context of quality management and international trade, UKCE is not an official term. It is most likely a combination of the two major conformity marks you need to know for the British and European markets: UKCA and CE
The USFDA (United States Food and Drug Administration) serves as the federal agency that protects public health through its responsibility to evaluate and approve the safety and effectiveness of all human and veterinary drugs and biological products and medical devices.
For a quality management professional, “FDA Compliance” is the gold standard for entering the American market. The FDA functions as the primary regulatory authority and chief auditing body while the EU’s CE marking system depends on third-party organizations to conduct its certification process.
|
Class
|
Risk Level
|
Example
|
Typical Pathway
|
|---|---|---|---|
|
Class I |
Low Risk |
Bandages, sunglasses, |
General Controls (Most are exempt from pre-market review). |
|
Class II |
Moderate |
Powered wheelchairs, |
510(k) Clearance (Must prove it is |
|
Class III |
High Risk |
Pacemakers, heart valves, |
PMA (Premarket Approval) |
MDSAP stands for the Medical Device Single Audit Program. It is a high-level regulatory program that allows a single audit of a medical device manufacturer’s Quality Management System (QMS) to satisfy the requirements of multiple different countries simultaneously.
The USFDA (United States Food and Drug Administration) serves as the federal agency that protects public health through its responsibility to evaluate and approve the safety and effectiveness of all human and veterinary drugs and biological products and medical devices.
ISO 13485 establishes quality management processes which guarantee medical devices will be produced at consistent high standards.
ISO 13485 certification exists as a requirement for medical device manufacturers through multiple countries which use the standard as their regulatory foundation. The certification process provides organizations with a pathway to meet regulatory requirements while entering new markets.
ISO 13485 certification functions as a business requirement in some countries while specific customers demand it for their operations. The certification process enables companies to access international markets.
The standard requires organizations to implement risk management procedures during all stages of product development which results in safer products and decreased manufacturer liability.
Operational efficiency will improve when organizations implement ISO 13485 practices because they enable better operations and decrease mistakes and rework processes which results in financial benefits.
ISO 13485 certification enhances an organization’s reputation because it shows customers and stakeholders that the company prioritizes quality and safety standards.
ICMED (Indian Certification of Medical Devices) is India’s first indigenously developed quality certification scheme for medical devices. Launched as a joint voluntary initiative by the Quality Council of India (QCI) and the Association of Indian Medical Device Industry (AiMeD), it is designed to fill the regulatory gap and enhance the “Make in India” brand globally.
While the Indian Medical Device Rules (MDR 2017) are mandatory for legal sale, ICMED is a voluntary “Quality Mark” that proves a manufacturer goes above and beyond the minimum legal requirements.
ICMED is structured into three tiers based on the complexity and risk of the device:
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Level
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Based On
|
Target Group
|
|---|---|---|
|
ICMED 9000 |
ISO 9001 + Indian Regulatory |
Low-risk devices (Class A) where simple quality management is sufficient. |
|
ICMED 13485 |
ISO 13485 + Indian |
Medium-to-high risk devices. It ensures |
|
ICMED 13485 Plus |
ICMED 13485 + |
This is the highest level. It includes |
(Good Manufacturing Practice) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical or medical device production that cannot be eliminated through testing the final product.
Validation requires you to demonstrate that your equipment and processes operate according to their intended functions. (e.g., “Does this oven actually stay at 180)
Documentation (Good Documentation Practice) requires that every action must be recorded at the time it occurs. The saying “If it isn’t written down it didn’t happen” exists because of this fact.
Contamination Control: The organization enforces strict regulations regarding airflow operations and water quality standards and “Cleanroom” environments to prevent any dust or microbes or chemicals from entering the product.
Batch Traceability: The ability to track a final product requires access to both the particular raw material batch and the individual workers who handled it.
CAPA conducts formal operations to manage deviations while determining their main causes and creating measures to stop future occurrences.
GLP (Good Laboratory Practice) serves as a quality system which governs the entire process of non-clinical health and environmental safety studies from their initial planning through to their final reporting.
GLP guarantees that laboratories deliver trustworthy data to regulatory bodies such as the FDA and EMA because it establishes standards for testing which can produce consistent results that authorities can verify. The system prevents data fraud while guaranteeing that study outcomes accurately represent the research conducted.
His is the most common meaning in the medical device and pharmaceutical industries. It refers to the quality system that ensures products are consistently stored, transported, and handled under suitable conditions from the manufacturer to the end-user.
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