Biomedical credentials, codes & rules.

Requires: One of: bachelor's + 3 yrs regulatory/regulatory-related experience; master's + 2 yrs; doctorate + 1 yr; or 10 yrs regulatory experience regardless of degree. 100 multiple-choice questions, 120 minutes, computer-based.

Renewal: 36 recertification credits every 3 years

Requires: Same as RAC-Devices: bachelor's + 3 yrs regulatory experience; master's + 2 yrs; doctorate + 1 yr; or 10 yrs experience. Covers pharmaceutical/biologic/biotech regulations.

Renewal: 36 recertification credits every 3 years

Requires: Bachelor's degree in relevant field and documented clinical engineering experience; written and oral exams administered by US/Canadian Boards of Examiners.

Renewal: Every 3 years: minimum 15 continuing-practice points over 36 months with at least 2 points in at least 3 of 4 categories

Requires: ABET-accredited engineering degree, pass NCEES Fundamentals of Engineering (FE) exam, typically 4 years of qualifying experience under a licensed PE, pass NCEES Principles & Practice (PE) exam. Note: NCEES offers NO biomedical-specific PE exam; biomedical engi

Renewal: State-dependent, typically biennial with continuing-education PDH requirements (most states 15-30 PDH/year-equivalent)

Requires: One of: associate+ degree in biomedical equipment technology + 2 yrs full-time BMET experience; US military BMET program + 2 yrs; associate+ in electronics + 3 yrs; or 4 yrs full-time BMET experience. 165 multiple-choice questions, 3 hours.

Renewal: Every 3 years (renewal fee)

Requires: Typically requires CBET-level background; healthcare technology management experience; exam covering management of medical equipment programs.

Renewal: Every 3 years

Requires: 8 years on-the-job experience in CQE Body of Knowledge areas, 3+ years in a decision-making position (education waivers: bachelor's -4 yrs, master's/doctorate -5 yrs). 175 multiple-choice questions (165 scored), ~5h18m, open-book.

Renewal: Every 3 years: 18 recertification units (RUs) or retake exam

Requires: 5 years full-time paid experience in CBA Body of Knowledge areas, at least 1 year in decision-making position; or ASQ society membership / PE registration as proof of professionalism. 135-question, 4-hour written exam, English only.

Renewal: Every 3 years: 18 recertification units (RUs) or retake exam

Requires: 3 years full-time experience in Six Sigma Black Belt Body of Knowledge PLUS at least one completed Six Sigma project with signed sponsor affidavit (or a second completed project). ~150 scored questions, ~4h18m, open-book. ANAB-accredited under ISO/IEC 17024.

Renewal: Every 3 years: 18 recertification units (RUs) or retake exam

Requires: Working knowledge of ISO 13485 and internal audit experience strongly recommended. Course covers Exemplar Global TPECS units MD (Medical Device Systems), AU (Management Systems Auditing), TL (Leading Audit Teams); CQI/IRCA course code PR369 (5 days, 40 hours,

Renewal: CQI/IRCA Certificate of Achievement valid 5 years from exam date for auditor certification purposes

Requires: Not applicable — process standard; certification available from accredited registrars (BSI, SGS, TUV SUD, DEKRA, etc.)

Renewal: Not applicable (organizational certification cycles: 3-year audit cycle)

Requires: Not applicable — testing/certification performed by accredited labs (TUV, Intertek, UL, BSI)

Renewal: Not applicable

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Requires: Applies to finished device manufacturers commercially distributing devices in the US; establishment registration and device listing with FDA.

Renewal: Ongoing compliance; verified by FDA inspection (no certificate issued)

Requires: Device of low-to-moderate risk with a legally marketed predicate; demonstration of substantial equivalence (intended use + technological characteristics). Bench/biocompatibility/software testing; clinical data only if needed.

Renewal: One-time clearance per device/version; new 510(k) for significant changes

Requires: High-risk devices (sustain/support life, implantable, unreasonable risk of illness/injury) with no predicate; valid scientific evidence of safety and effectiveness — generally pivotal clinical trial data, full manufacturing controls, inspections.

Renewal: Approval with conditions: annual periodic reports, post-approval studies; PMA supplements required for changes

Requires: CE marking via conformity assessment with a Notified Body (all classes except Class I non-sterile/non-measuring); QMS per Article 10(9), clinical evaluation, UDI, EUDAMED registration.

Renewal: CE certificates max 5 years; QMS audits and unannounced audits ongoing

Requires: CE marking; under IVDR ~80% of IVDs need Notified Body review (vs ~20% under old IVDD); performance evaluation, PMS/PMCF; QMS per IVDR Art 10.

Renewal: CE certificates max 5 years; ongoing surveillance

Requires: Applies to covered entities (health plans, clearinghouses, providers transmitting health info electronically) and their business associates — device makers are typically NOT covered entities but become business associates when handling PHI on behalf of one (co

Renewal: Ongoing: security risk analysis required; business associate agreements (BAAs); breach notification

Requires: Cyber devices: submit threat modeling, architecture views, SBOM (machine-readable), vulnerability assessment, and a postmarket vulnerability-management plan with premarket submission.

Renewal: Postmarket: monitor, assess, patch vulnerabilities; coordinated disclosure

Requires: Not applicable — no US state issues a 'clinical engineer' or 'biomedical engineer' license; hospital engineers work under PE-licensed engineers, facility accreditation (Joint Commission, NFPA 99 for health care facilities), and state health-department facility

Renewal: Not applicable