What are examples of a Combination Product (Medical device and Pharmaceutical) ?

ISO 13485 - Medical

Involved In Discussions
#1
Does anybody know of a medial device that is also a pharmaceutical product.

The claims will change but the pharmaceutical product will be used with a device, i.e in a spray but with no medicinal claims.
 
Elsmar Forum Sponsor

ISO 13485 - Medical

Involved In Discussions
#3
Re: Medical Device and also a Pharmaceutical Product

thanks for getting back,

it a device that is already in the market place that is also a pharma product, i was looking to find if there is anything?
 

ISO 13485 - Medical

Involved In Discussions
#5
Re: Medical Device and also a Pharmaceutical Product

The device will be used in the EU. The Pharma part of the device will be used as a drug on its own, but can this also be used as a combo device?
 

AnaMariaVR2

Trusted Information Resource
#9
Re: Medical Device and also a Pharmaceutical Product

FDA's Approvals & Clearances:

FDA Approves Neupro Patch for Treatment of Early Parkinson's Disease
http: //www .fda. gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108912.htm - DEAD LINK (404) UNLINKED

FDA Approves Methylphenidate Patch to Treat Attention Deficit Hyperactivity Disorder in Children
http :// www. fda .gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108633.htm - DEAD LINK (404) UNLINKED

FDA Approves Emsam (Selegiline) as First Drug Patch for Depression
http :// www. fda. gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108607.htm - DEAD LINK (404) UNLINKED

FDA's Combination Products: Meetings, Conferences, & Workshops
Presentations, articles, and information about combination product meetings.
Combination Products Meetings, Conferences, & Workshops

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM147095.pdf
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
M Combination products - examples CE Marking (Conformité Européene) / CB Scheme 1
qualprod Examples to mitigate risk from Covid ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Two excellent examples of process capability analysis from Quality Magazine Capability, Accuracy and Stability - Processes, Machines, etc. 5
U Examples of Quality Objectives for a Medtech start up ISO 13485:2016 - Medical Device Quality Management Systems 4
B ITAR Visitor Log Examples AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
E Non-GMP examples in Pharmaceutical industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
I Quality Policy and Objectives examples Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 5
Y Examples of TRB Reports for MIL-PRF-31032 Qualification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
I ISO 22000:2018 - Operational Prerequisite Program Examples Food Safety - ISO 22000, HACCP (21 CFR 120) 2
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
M Where can I find examples of PPAP? APQP and PPAP 6
O Examples of Critical process parameter (CPP) and Critical quality attribute (CQA) Manufacturing and Related Processes 2
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L IATF 16949 8.3.3.2 FCA (Fiat Chrysler) Specific Requirements - Examples of AQR and MPFMEA Service Industry Specific Topics 1
L IATF 16949 Warranty Management System examples IATF 16949 - Automotive Quality Systems Standard 0
A Examples of Pre-Sub, SRD, PMA Shells and Templates Other US Medical Device Regulations 3
S IAF Codes - Examples of what falls under each code General Information Resources 2
R Examples of inherent safety by design ISO 14971 - Medical Device Risk Management 83
O Examples of the external and internal issues and their risks and opportunities IATF 16949 - Automotive Quality Systems Standard 2
M Medical Device Traceability Matrix - Examples EU Medical Device Regulations 8
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
Ajit Basrur Looking for examples of "User Training" - ISO 13485 section 7.2.1 d) ISO 13485:2016 - Medical Device Quality Management Systems 6
S Manufacturing Work Instruction examples that include process pictures Manufacturing and Related Processes 3
G Uncertainty Budget Examples for Caliper, Micrometer and Dial Gauge Measurement Uncertainty (MU) 3
Albert G. What are general examples of audit findings with ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Q Risks Examples in Top Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna Blockchain Technology - Any examples of practical application? The Reading Room 21
Z SAP Validation for Part 11 Compliance - Examples (executed protocols) Qualification and Validation (including 21 CFR Part 11) 3
M How to Document Internal & External Communications - Suggestions/examples pls IATF 16949 - Automotive Quality Systems Standard 3
Y Examples of Risk and Opportunities based on ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Examples of Quality Objectives related to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
M CAAC-145 Manuals - Looking for examples of MOM's, MMM's Capability Lists, etc. Federal Aviation Administration (FAA) Standards and Requirements 13
D Seeking Corrective Action Process Examples Nonconformance and Corrective Action 3
P ISO 9001:2008 Design and Development Process & Forms examples wanted Design and Development of Products and Processes 3
K AS9100 5.3 Authorities (Looking for examples) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
F ISO 14001:2015 EMS Procedures and Form Examples wanted ISO 14001:2015 Specific Discussions 10
K EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols Other Medical Device Related Standards 3
A SIPOC (Suppliers Inputs Process Outputs Customers) examples wanted Quality Manager and Management Related Issues 1
A AS 9100 - Risk Management Procedure and Flow Chart examples AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Aseptic Sampling Procedure Examples (Syringe and Dipper) wanted Manufacturing and Related Processes 1
S Customer Scorecard Analysis Templates and Examples IATF 16949 - Automotive Quality Systems Standard 3
H Root Cause Corrective Action Examples Nonconformance and Corrective Action 4
S Seeking examples of Nonconforming Materials Nonconformance and Corrective Action 5

Similar threads

Top Bottom