Shipped Products Liability After 510k Ownership Transfer

A

Alister

Registered
Say, new owner of 510k is "B" and old owner was "A".
My question here is does "B" have liability on products (e.g. poor quality) that were shipped into the market when the 510k ownership was under "A"
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Q Control of outsourced processes - drop shipped products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Distribution Center has shipped Sterile Medical Device products that have Expired EU Medical Device Regulations 2
9 Responsibility for Product Paid for but not yet Shipped AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
JoshuaFroud CE Marking and Brexit - Product shipped to a distributor prior to the March deadline EU Medical Device Regulations 2
J Recall Effectiveness - Accessory to Medical Devices shipped through Distributors Customer Complaints 3
Z How does Japanese Customs Clear and Control Devices shipped into Japan? Japan Medical Device Regulations 3
R Declaration of Conformity Paper Copy Shipped with Product? CE Marking (Conformité Européene) / CB Scheme 1
A Shipping Procedure template - To include picked, verified and shipped by information Document Control Systems, Procedures, Forms and Templates 3
A How do I set up a PPM with Total pcs shipped vs. Total Scrap for the month Statistical Analysis Tools, Techniques and SPC 10
D CSA Inspection - Process equipment shipped elsewhere to process product Various Other Specifications, Standards, and related Requirements 9
L Big Shipping Error - Shipped without the CE mark on them - Need advice! CE Marking (Conformité Européene) / CB Scheme 5
D RIPs should be labeled and not shipped. What are RIPs in ISO/TS 16949:2002? IATF 16949 - Automotive Quality Systems Standard 5
M Paint booth prints - Painters using them as ?ground cloth? after the job is shipped Document Control Systems, Procedures, Forms and Templates 2
H FCC Certification of an intentional radiator category products CE Marking (Conformité Européene) / CB Scheme 6
A Screenshot guidance for removal of Cosmetic products from MHRA UK Medical Device Regulations 1
T Clinical Study Design for IVD Self-Test (lay user) Products UK Medical Device Regulations 0
Leigh76 CE Marking of Class II Bulk NonSterile Products for Kit Packers EU Medical Device Regulations 1
H LM Transfer and MDD products in Supply chain ISO 13485:2016 - Medical Device Quality Management Systems 0
V Regulatory consultants for US FDA ANDA - pharma / drug products Consultants and Consulting 0
G Control of Externally Provided Processes, Products, and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
dgrainger Informational Published - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI EU Medical Device Regulations 1
D API Q1 clause (5.6.3) Verification of Purchased Products or Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D 8.3.2.1 Review of the Requirements for Products and Services. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D 8.2.3.1 Review of the Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M DHF for drug products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
H Is CE valid in Switzerland for self certified products? CE Marking (Conformité Européene) / CB Scheme 5
G Regulations for research products in Europe EU Medical Device Regulations 0
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
M CE marking for RUO products EU Medical Device Regulations 0
V Review of the Requirements of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
O MDD products under MDR certificate EU Medical Device Regulations 12
dgrainger Informational Draft for comment - "reclassification of products without an intended medical purpose" EU Medical Device Regulations 6
J Assigning UDI's for own brand products EU Medical Device Regulations 11
D Do all products fall under scope of AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
C Can I apply First Time Yield (FTY) for several products or processes of different nature? Manufacturing and Related Processes 5
R CE marking of products not sold into the EU CE Marking (Conformité Européene) / CB Scheme 4
D Is sampling allowed for MDR Class III products? EU Medical Device Regulations 0
dgrainger Informational DRAFT - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI. EU Medical Device Regulations 0
A EO Residual for Sterilization of Implantable Products Medical Device and FDA Regulations and Standards News 6
B Re-use of ETO Sterilized products Medical Device and FDA Regulations and Standards News 6
P Can I exempt products/services from my AS9100 QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S One formulation for two products/brand names (MD/cosmetics) EU Medical Device Regulations 0
N Change Control for processes & products Manufacturing and Related Processes 7
C CBD based products registration in EU and UK EU Medical Device Regulations 4
R Role of QA during Design and Development of Products and Processes Design and Development of Products and Processes 4
E China PPE Products Regulation Registrars and Notified Bodies 1
R CE and UKCA marking Own Brand products CE Marking (Conformité Européene) / CB Scheme 0
R QMS for Medical products & Pharmaceutical Drugs in one facility Medical Device and FDA Regulations and Standards News 3
T Non API products need to comply to API Q1? Oil and Gas Industry Standards and Regulations 3

Similar threads

Top Bottom