Integrating compliance/product certification into the design process - overview
In order to provide the shortest design cycles and first-to-market launches, contract designers must process the same amount of work in less time. One possible solution is to redirect the regulatory submission work from the transfer phase to the design and development phase.
For example, Medical Electrical Equipment (ME) manufacturers must demonstrate that their development plans include specific steps such as identifying and describing risk management activities, the design life cycle phases these activities take place, including their verification and review requirements. For products containing software, designers must document traceability between safety standard requirements, software requirements, system requirements and risk control measures.
By involving compliance engineers in the beginning design phases regulatory issues can be identified and resolved without having to wait until the later stages of development or first production runs. This approach also creates parallel paths to process the regulatory work, eliminating the reliance on the Certification Body (CB) to process the work in a serial fashion at the end. The contract design house regains control and visibility over the outcome of the regulatory review as opposed to leaving it to chance during the regulatory submission.
The return on investment will yield:
- Reduced probability of redesign, board spins, additional prototypes
- Reduced probability of test failures and/or non-compliances
- Reduced cycle time through certification labs
- Reduced probability of questions/issues from FDA 510(k) submittal
Responsibilities of the contract design house
From the CB perspective, the company responsible for the design of a medical product is responsible for complying with the engineering process requirements. Through the evolution of ME equipment standards, CB’s review the designers/manufacturers engineering processes for compliance. Significant delays could occur if the entity responsible for the design fails to properly document compliance with the following standards:
- Usability (IEC 60601-1-6)
- Risk Management (ISO 14971)
- Programmable Electrical Medical Systems (PEMS) (Clause 14 of IEC 60601-1) and
- Software development (IEC 62304)
As the Design History File (DHF) transfers to the ME manufacturer from the design house, traceability back to the design process is often lost.
*Note: If the design processes weren’t followed or documented properly, the CB is unable to issue certification.
Solutions for the medical company and the contract design/manufacturer
Include compliance engineers in the beginning development phases to review:
- Applicable Safety Standards
- Regulatory requirements for different geographies
- Certification Scheme requirements (e.g. NRTL, CB)
- Strategies for cost effective design (financial impact based on risk control chosen)
- Realistic scheduling
During the middle phases of design, reviews conducted by compliance engineers can ensure:
- Plans include the required elements (e.g. risk acceptability policy and criteria, validation requirements)
- Hazard analysis includes risks specifically required by the standard
- Traceability established between hazards and risk controls
- If additional requirements are introduced as a result of the risk management process (i.e. Alarms [IEC 60601-1-8] or Essential Performance)
- Safety component selection (approved BOM)
- Pre-compliance testing (electrical, mechanical)
A contract design company was used as the example; however, the above strategy applies to any ME manufacturer. Through early engagement with the CB the return on investment will be high for companies who do not have experienced compliance engineers on staff. For larger companies with in-house compliance engineers, early engagement can reduce regulatory submission times by completing significant portions of work during the middle design phases as opposed to a single critical path through the CB at the end of the design cycle.
Read More & Download: Take control of product certification
For more information, contact:
Mitchell C. McGarry, Engineering Leader , UL LLC
Email: [email protected]
Phone: +1 (714) 223 3629