Product Compliance Roadmap
REQUIREMENTS IDENTIFICATION (or review for gap analysis with existing products)
- Identify intended use of product
- Identify applicable regulatory jurisdictions (based upon client's distribution targets)
- Identify product's classification
- Identify RA submission requirements
- Identify applicable standards
- Identify safety agency certification requirements
- Identify process requirements for risk management, usability, and software life-cycle
INITIAL PRODUCT ASSESSMENT
- Evaluate product's construction against applicable standards
- Review operating instructions and device markings for test applicability
- Generate isolation diagram to document electrical means of protection
- Identify and review critical components for conformity requirements
- Review risk management, software and usability engineering files for test applicability
- Identify applicable tests
- Manage preliminary safety & EMC testing as part of client's engineering design verification (optional upon request)
- Issue initial evaluation & preliminary test reports for client's in-house verification needs (optional upon request)
- Issue risk management tables, as applicable to standard (optional upon request)
- Work with client to resolve any initial non-conformities, test failures, and process deficiencies
FORMAL COMPLIANCE TESTING (conducted by an accredited test laboratory -- or multiple laboratories, as appropriate -- after initial non-conformities have been resolved)
- [Compliance on Tap] Define safety mark and report requirements, as required by the project scope and the client's regulatory approval objectives
- [Compliance on Tap] outsource testing to a test laboratory with the appropriate accreditations (i.e. NRTL, CB Scheme, etc)
- [Compliance on Tap] Assist client with initiating service agreements with test lab, as required
- [Test Lab] Obtain production-equivalent samples with documentation and verify operation
- [Test Lab] Document product's construction and means of protection
- [Test Lab] Photograph product showing its dimensions and safety-critical construction features
- [Test Lab] Test according to the base standard, as well as applicable collateral and particular standards and national differences
- [Test Lab] Report back on test results and inform client of any test failures or residual product non-conformities
- [Compliance on Tap] Assist client to resolve testing & non-conformity issues reported by test lab
- [Test Lab] Conduct retesting, as appropriate
- [Test Lab] Issue test data report or test results summary
FORMAL COMPLIANCE REPORTING (test laboratory writes compliance report covering general standard, collateral standards, particular standards, national differences, using applicable IECEE checklists)
- [Compliance on Tap] Liaise between client and test laboratory to address test lab's issues or additional information requirements
- [Test Lab] Fill-in prduct description and insulation diagram
- [Test Lab] Fill-in checklist verdicts
- [Test Lab] Fill-in test data tables and risk management tables (where appropriate)
- [Test Lab] Fill-in table of critical components
- [Test Lab] Prepare and attach supporting documents to report: photographs, instructions for use, illustrations including applicable drawings and schematics
- [Test Lab] Conduct a technical review, address any review findings, and issue compliance report along with authorization to apply their safety mark and/or a CB Report and CB Certificate (as defined by the outsourced project scope)
NEXT STEPS
- [Compliance on Tap] Advises client on next steps towards obtaining regulatory approvals and accommodating the test lab's NRTL follow-up inspection requirements (as applicable)
Field Evaluations
Uncertified electrical and medical products which don't require regulatory clearance, but which are still subject to safety approvals in accordance with the electrical code and safety authority requirements (i.e. OSHA and State safety authorities in the USA, SCC and Provincial safety authorities in Canada), may be eligible for approval under the Field Evaluations Program (per the relevant UL Standards, USA) and the Special Inspections Program (per SPE1000 & SPE3000, Canada). Such products don't undergo full certification and the safety inspection can usually be carried out by an agency within one day onsite.
Products which fall into this category include:
- custom-built equipment
- low-volume electrical products
- large installations where the combination of equipment requires approval
- equipment imported from another country which bears certification marks relevant to its country of origin, but which lacks North American certification (i.e. CE-Marked equipment imported from Europe)
- investigational medical devices
Compliance on Tap can assist with:
- identifying the relevant program and Standards
- identifying the Authority Having Jurisdiction (AHJ) at the point where the product will be installed and used
- reviewing your product's construction to determine whether there are any compliance issues which need to be addressed prior to its inspection
- initiating contact with a suitably-accredited agency on your behalf and coordinating the inspection
Technical File Preparation
Technical files of various types are the cornerstone for obtaining regulatory approvals and for maintaining them following design changes. Their exact content requirements vary from jurisdiction to jurisdiction, however they all provide the supporting technical information showing in detail how the design and implementation of the product meets the jurisdiction's regulatory requirements for safety, efficacy and other licensing considerations.
At Compliance on Tap, we have extensive experience with compiling technical documentation to support regulatory applications and we can help with your specific needs, including preparing the technical file and initiating the regulatory submission process.
A brief overview of the Canadian, US, and EU medical device requirements follows.
Canadian requirements, Medical Devices Regulation (SOR/98-282):
- Health Canada requires the manufacturer to register their establishment and to obtain a license for the device(s) to be marketed
- manufacturer must attest that the device meets the Safety and Efficacy requirements (Cl. 10-20 incl.) and sumit a copy of the device's labeling (see Labeling Requirements, Cl. 21-23) as part of the application
- At the same time, the manufacturer must have a registered ISO13485:2016 QMS and follow the product realization processes of this Standard from start to end
- Technical File requirements are as spelled out in Cl. 4.2.3 Medical Device File, which in practice is a combination of the device's formal production documents (i.e. "device master record") and its design documents, including plans, requirements, design output, verification, validation, risk management file, transfer to production, process validation, and traceability of requirements throughout each stage of the design process to demonstrate that all of the requirements were fulfilled
- classification of devices is from Class I through Class IV
USA requirements, US Food and Drugs Act - Medical Devices (21 CFR 800-1299):
- FDA requires the manufacturer to register their establishment (whether US-based or foreign-based with a US Representative) and, in most cases, to obtain either 510(k) market clearance (Class 1 where applicable and all Class 2 devices) or PMA market approval (Class 3 devices and other devices which are not eligible for the 510(k) process)
- FDA requires the manufacturer to design the medical device and the process used to manufacture it following the Quality System Regulation (21 CFR 820)
- The Technical File consists of the actual regulatory application, its contents, and all of the technical design & manufacturing documents which support it, including the DHF (21 CFR 820.30(j)) and DMR (21 CFR 820-181)
EU requirements, CE-Marking according to Medical Devices Directive (93/42/EEC) & Medical Devices Regulation (EU 2017/745):
- CE-Marking approval is obtained through a Notified Body
- Submission includes a copy of the Essential Requirements checklist, which shows how each of the applicable requirements is fulfilled by referencing documents within the Technical File
- The Technical File itself is compiled according to the guidance document "NB-MED/2.5.1/Rec5 Technical Documentation" and it consists of (a) select documents from the design history including design plans, requirements, design output, verification, validation, risk management file, transfer to production, process validation, and traceability of requirements throughout each stage of the design process to demonstrate that all of the requirements were fulfilled; (b) manufacturing documents and; (c) clinical evaluation documents
- in addition to the Technical File, a Design Dossier is required for the highest risk devices
- device classification includes Class I, Class IIa, Class IIb, and Class III
Regulatory Submissions Roadmap
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