Frank Wang

About Frank Wang

With over 20 years of working experience in the medical device industry, Frank Wang specializes in regulatory compliance and quality management for medical monitoring accessories and consumables, including temperature probes, SpO₂ sensors, ECG cables, blood pressure cuffs, and fetal monitoring probes. As Regulatory Affairs Manager, his core focus covers regulatory practice for monitoring-related consumables, quality system establishment, global medical device market access, post-market surveillance, and risk management.

Frank possesses solid hands-on experience in implementing quality management systems and regulatory compliance frameworks such as NMPA, CE MDR, and FDA 21 CFR Part 820 QMSR. Under his leadership, Orantech successfully passed an FDA factory inspection with zero 483 observations — a direct reflection of the rigor of the quality systems he has built and maintained.

Global Regulatory Compliance Framework

Quality System Foundation Driving Registration & Audits — Regulatory Compliance Framework

Quality System Foundation

ISO 13485 QMS
CE MDR
FDA 21 CFR Part 820 (QMSR)

The quality system underpins every regulatory activity below

Product Registration & Market Access

NMPA Registration
EU CE MDR
US FDA 510(k)
UK / Switzerland & Other Markets

Audit & Inspection

FDA Factory Inspection (Zero 483)
Notified Body Audits
Customer Factory Audits

Lifecycle Assurance — Continuous Loop

3Q Qualification (IQ/OQ/PQ)
Post-Market Surveillance
Risk Management (ISO 14971)
CAPA & Continuous Improvement

Professional Journey

Mar 2022 — Present

Regulatory Affairs Manager

Orantech Inc.

Fully manages team administration and daily operations of the regulatory quality department; establishes and maintains compliance systems including ISO 13485, CE MDR, and FDA 21 CFR Part 820 (QMSR). Leads product registration for NMPA, CE MDR, FDA, as well as multiple global markets including the United Kingdom and Switzerland. With in-depth comprehension of FDA 21 CFR Part 820 (QMSR), successfully passed FDA factory inspection with zero 483 observations. Oversees internal audits, management reviews, customer factory audits, and audit response activities. Drives process standardization and facilitates cross-functional collaboration among R&D, manufacturing, procurement, and marketing teams.

Jun 2016 — Feb 2022

Regulatory & Quality Manager

Shenzhen Launch Medical Co., Ltd. — Medical Device Manufacturer

Took full charge of overall quality control operations for a medical device manufacturer; established, implemented, and maintained quality management systems including ISO 13485, CE MDR, and FDA 21 CFR Part 820. Delivered professional quality management and compliance audit services for world-leading international enterprises such as Medtronic, GE, and Philips. Planned, deployed, and implemented medical device 3Q process qualification (IQ: Installation Qualification; OQ: Operational Qualification; PQ: Performance Qualification). Responsible for domestic NMPA and EU CE product registration. Handled customer complaints, conducted supplier evaluation and coaching, organized internal audits and management reviews. Chaired KPI and quality-focused meetings to achieve quality objectives and reduce product non-conformities.

Apr 2010 — May 2016

Quality Supervisor

TK Group — Hong Kong–Based Manufacturing Group

Managed quality team operations at a medical device manufacturer; deployed multiple quality management systems including ISO 9001, ISO 13485, ISO/TS 16949, and ISO 14001. Organized internal audits, KPI reviews, supplier quality meetings, and supplier capability improvement initiatives. Prepared for overseas customer audits, promoted cross-functional quality improvement projects, and served as Management Representative for multiple system standards.

May 2004 — Mar 2010

QA Engineer

Vincent Medical Co., Ltd. — Hong Kong–Listed Medical Products Manufacturer

Conducted quality system maintenance, customer-complaint investigation, and interfaced with Notified Bodies and FDA on-site audits. Implemented SPC (Statistical Process Control) within laboratory operations. Developed profound expertise in global medical device regulations, covering FDA 21 CFR Part 820 and registration under EU Directive 93/42/EEC.

Education & Training

Education

Henan Polytechnic College

Major in Computer Science and Technology — College Diploma

Value-Added Training

EN ISO 13485
FDA 21 CFR Part 820 QMSR
CE MDR (Medical Device Regulation 2017/745)
NMPA Medical Device Quality System Regulations and Registration
EN ISO 14001
EN ISO 9001
EN ISO 14971
ISO/TS 16949
Good Manufacturing Practice for Medical Devices (GMP)
EU MDD 93/42/EEC

Areas of Expertise

Quality System Establishment & Operation (ISO 13485 / CE MDR / FDA QMSR)

Global Medical Device Registration (NMPA / CE MDR / FDA 510(k))

Audit Management

Medical Monitoring Accessories Compliance

Internal Audit & Management Review

CAPA Implementation

3Q Process Qualification (IQ/OQ/PQ)

Product Filing for Medical Monitoring Accessories

UK / Switzerland & Multi-Market Registration

Notified Body Audits

Overseas Customer Factory Audits

Non-conformity Rectification & Closure

Complaint Handling & Root Cause Analysis

Quality KPI Formulation & Defect Reduction

Supplier Quality Management

Process Standardization

What Frank Writes About

Frank has extensive practical experience in quality control and regulatory affairs for medical monitoring accessories (including temperature probes, SpO₂ sensors, ECG cables, blood pressure cuffs, and fetal monitoring probes). His articles focus on:

Interpretation of Right to Repair Policy

FDA 510(k) Process

Interpretation of CE Certification

ISO 13485 Quality Management System

FDA Compliance for EtCO₂ Products

Connect with Frank

Identity Verification: Frank Wang's professional background can be verified on the Orantech official About Us page. He is the Regulatory Affairs Manager at Orantech Inc., with over 20 years of experience in regulatory affairs practice for the medical monitoring accessories sector.