Competitor not complying with regulations (EU)

Nhund

Registered
#1
Dear Experts,

I work for a medium sized medical device company in Europe focused on electromedical devices.

We have a local competitor who is able to out perform us in regards to getting new products and features on the market. This has caught our attention and we have reason to believe that they either outright cheat in regards to the regulatory aspects or (perhaps more likely) are somehow able to get away with doing less that us. We do not have any proof of wrongdoing - only a strong suspicion. Two examples:

1) On their ISO 13485 certificate they list "production and sales" but do not include "product development". We know for a fact that they have invested in product development activities.

2) They have two products listed on their certificate. Each of these cover a broad and heterogeneous group of devices that are similar only in name.

Our competitor is about the same size as us and generally employ people with shorter educational backgrounds that us.

My question: how can we be assured that our competitor is following the rules? Who should we report our suspicions to?

Best regards
Frank
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Frank,
Regarding your first point, it is possible that they outsource the development to someone else (a contract developer).

I am not sure who you should report your concern, after have collected substantial evidence. But I think your notified body should be able to guide you about that.

Shimon
 
Thread starter Similar threads Forum Replies Date
J PMS Competitor Device product data from (MAUDE or TPLC) ISO 14971 - Medical Device Risk Management 3
R Does FDA require monitoring competitor device failures for preventive action? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Auditing Suppliers - Supplier audit by a customer who is also a competitor Supplier Quality Assurance and other Supplier Issues 13
U The Hidden Competitor The Reading Room 9
B QFD (Quality Function Deployment) - World Class / Competitor Benchmarking Benchmarking 3
J Competitor to audit us to TS16949 or ISO9001 General Auditing Discussions 13
J Proprietary PPAP documents - Customer is also our competitor APQP and PPAP 5
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
F Complying with ISO 17025 by UNIDO ISO 17025 related Discussions 0
qualprod Shortening processes complying with process approach ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod Complying with ISO 9001:2015 - 9.1.1 b - Monitoring, measuring, analyzing and evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Complying with IATF 16949 Cl. 8.4.2.1 - Type and extent of control IATF 16949 - Automotive Quality Systems Standard 1
M Complying with AS9100 D Section 8.4.3 m. Ensuring that persons are Aware of... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
S Suggestions or advice on complying with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q ISO 9001 Certified but not complying with ISO clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
I Does being a subsidiary fully absolve company B from complying with 21 CFR 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Failure of X-Capacitors complying with IEC 60384-14 IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
N Complying with ISO 9001 7.6 - Customer Provided Computer and Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Unified Quality Policy sample complying to 9001-14001-18001 Misc. Quality Assurance and Business Systems Related Topics 18
B Complying with ISO 14001 Clause 4.4.4 "Document Interaction" ISO 14001:2015 Specific Discussions 9
I Acceptability of Existing Devices complying to IEC 60601-1 2nd Edition after Jun'2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
N Complying with AS9102 when the supplier is using 3D Model Based Definition (3D MBD) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Customer Focus - Complying with TS 16949 clauses 7.2.1 and 8.2.1 IATF 16949 - Automotive Quality Systems Standard 5
J Control of Records - Complying with ISO 9001 Clause 4.2.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Complying with Change Notification Requests - Wholesale Distributor Quality Manager and Management Related Issues 7
K Complying with Ford customer requirement 4.35 Variable Gage Studies General Measurement Device and Calibration Topics 3
S Deadline for complying/replying to a Customer Complaint Customer Complaints 6
V Purchase Order Clauses - Complying with AS9100 clauses 7.4.2 e & f AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I Complying ISO 13485 - Require other documentation specified by regional regulations? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Configuration Management Simplified - Complying with AS9100 Clause 4.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
S CE Marking Question - Class IIa device by complying with Annex V & VII EU Medical Device Regulations 10
W Complying with ISO 9001 Calibration Requirements - Report Before and After Data General Measurement Device and Calibration Topics 12
D Complying with TS 16949 and QS-9000 Supplier (Subcontractor) Development Requirements Supplier Quality Assurance and other Supplier Issues 43
K Complying with the requirement for Contingency Plans - 4.9.b.2 QS-9000 - American Automotive Manufacturers Standard 44
G Brazil Regulations RDC 270/2019 Other Medical Device Related Standards 0
G No new regulations in Austria medical device register after 26th Mai, 2022 EU Medical Device Regulations 0
C Is there a list of products or classifications subject to medical device regulations in El Salvador? Other Medical Device Regulations World-Wide 0
B Rework of a medical device EU regulations EU Medical Device Regulations 5
L Single-cell lithium ion battery regulations IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L Saudi regulations for Japanese non sterile scopes Japan Medical Device Regulations 0
L ANVISA’s RDC 665 replaces previous regulations including RDC 16/2013 and IN 08/2013, and comes into effect on May 2, 2022 Other Medical Device Regulations World-Wide 0
M Seeking mentor/consultant for orthopaedic soft goods regulations Job Openings, Consulting and Employment Opportunities 0
D Regulations covering Sterile product shipments ISO 13485:2016 - Medical Device Quality Management Systems 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 1
R Regulations on Controlled Document Size (Paper Size) Document Control Systems, Procedures, Forms and Templates 4
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
N How to validate Regulations and Standards? ISO 13485:2016 - Medical Device Quality Management Systems 12
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
L EOL milestone in Medical Devices Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1

Similar threads

Top Bottom