Professional profile
About Haijiang
Medical Device and Implant Liability in Suzhou
Haijiang Wu advises medical device manufacturers, implant makers and distributors on product liability, regulatory compliance, clinical evaluation and commercial contracting from Suzhou.
Mr. Wu practices at a Suzhou law firm. He was admitted in 2013 and has about thirteen years of professional experience, working in English and Mandarin with Jiangsu Bar Association credentials on file.
Device files are multi-regulator and multi-contract. Registration classifications, clinical evaluation expectations, labelling, advertising claims and distributor quality agreements must align. Global HQ templates that ignore China-specific pathways create launch delays and inspection risk.
Implant Fracture and Product Defect Claims
Hospitals point at the device; manufacturers point at technique. Without an early dual-track evidence plan, the appraisal question is written by someone else.
Within seventy-two hours of notice, he secures the explant, packaging, implant card and UDI or lot record with chain of custody on paper. Design, manufacturing and complaint history for the lot family are pulled. IFU versions and training records for the implanting team era are held.
Insurers are notified; hospital communication is aligned so junior staff do not confess product fault. Appraisal framing, technique versus defect versus patient factor, often decides more than the closing argument.
FTO, Design-Around and IP Coordination
Engineers ask whether they can ship; lawyers answer with claim charts. He writes design-around memos that change CAD decisions before tooling is cut.
Prioritise patents that block the commercial embodiment, not every family member. Document alternative structures considered and why they still meet performance. Separate open literature from trade-secret process know-how that must not be disclosed casually in filings.
Re-run FTO when cost-down redesigns are forced; cheap copies attract patents and quality claims together. Adverse event and recall communications are sequenced with insurer and distributor notice duties.
How to Engage
Provide product type, registration status, lot and complaint history, and any inspection, recall or claim notice already received. Scope is confirmed in writing through this profile's inquiry channel.
Capability
