Electrical safety, EMC and product compliance

The situation

An electrical medical device, or an IVD instrument, is heading for testing. The laboratory wants to know which standards, which editions, which particular, which accessories and which modes, and the engineering team is not sure. Or the testing is done and the reports have come back, and someone needs to say whether they actually cover what the notified body or FDA will look for.

What goes wrong when this is handled late

The costly errors are specific. Testing to a superseded edition because that is what the laboratory's last quote said. Missing a particular standard that modifies half the general standard's clauses for your device type. Defining essential performance after the EMC testing rather than before it, so that the immunity tests monitored the wrong functions. Sending the device without the accessory that changes the applied-part classification. Receiving a 400-page report and filing it without noticing that three clauses were "not evaluated".

Each of these produces a retest, and a retest is the laboratory's full fee again plus the schedule.

What Authentcare does

Assess. Build the applicability matrix: the general standard, each collateral and particular that applies, the edition of each, and the national deviations for each target market. Lead the essential-performance exercise from the risk analysis. Review the device configuration, accessories and modes that must be covered.

Develop. Write the test plan and the laboratory brief so that the quotation covers the right scope and nothing is left to the laboratory's assumptions. Review the quotations. Prepare the documentation the laboratory needs: the risk management file extract, the essential-performance definition, the insulation diagram, the software and usability inputs.

Coordinate. Manage the laboratory relationship through the test programme. Review every report against the brief and the standard, clause by clause, and list the gaps. Plan the retest scope where one is needed. Integrate the results into the risk management file and the technical documentation, and prepare the summary a reviewer expects.

What the engineering background is, and is not

The founder spent four years in semiconductor design verification before regulatory affairs. That background brings a transferable method — requirements traced to evidence, a verification plan written before the test, a report read against the plan rather than skimmed — and a fluency with complex electronic and software systems that makes the conversation with your engineers faster.

It is not medical-device electrical-safety, EMC or hardware-verification testing experience, and this page does not present it as such. The testing is done by accredited laboratories; the value here is in what is asked of them and what is done with the answer.

What you receive

• Standards applicability matrix — general, collateral and particular standards with editions, and the market-specific national deviations that apply
• Essential performance identification, documented from the risk analysis and carried into the test plan
• Test plan and laboratory brief, including sample configuration, accessories, modes and the rationale for any clause excluded
• Laboratory selection support and quotation review, with no commercial affiliation to any laboratory
• Test report review against the brief and the standard, with a gap list and a closure plan
• Integration of electrical-safety and EMC results into the risk management file and the technical documentation
• Environmental compliance applicability assessment (RoHS, REACH, WEEE) where it applies

Frameworks and editions

Applicability is device-specific. Which of these apply, and in what combination, depends on device type, intended purpose, classification and target market; the applicability assessment at the start of every engagement settles it in writing.

What this engagement excludes

• Testing of any kind; accredited laboratories perform and invoice all tests
• Circuit or firmware design changes; recommendations are made, design is the manufacturer's
• Laboratory fees and sample shipping
• Certification marks and schemes such as CB Scheme certificates, which are issued by the laboratory and the national certification body