Fast Regulatory Compliance To Get Your Product Market Ready
Consultancy Services offered:
Design History Files (DHF) & Tech Files Remediation for legacy product compliance
Unique Device Identification (UDI) UDI Compliance services for market entry
Medical Device & Combination Products Extensive experience dealing with drug/device combination products as well as stand alone medical devices
Key Areas of Expertise
Verification & Validation
Labelling & IFU Requirements. Including Design Requirements
Design Control. As per 21CFR820
Technical File Completion
Biocompatibility
Risk Management. Process, User and Design Risk Management
Post Market Surveillance
QMS Procedure Creation & Updates
Regulatory Approval for
Revenue Generation
Supporting your goal of gaining access to
revenue generating markets
Key Areas of Expertise
Verification & Validation
Labelling & IFU Requirements. Including Design Requirements
Design Control. As per 21CFR820
Technical File Completion
Biocompatibility
Risk Management. Process, User and Design Risk Management
Post Market Surveillance
QMS Procedure Creation & Updates
Regulatory Approval for Revenue Generation
Supporting your goal of gaining access to revenue generating markets
Step by Step Project Management
Step by Step Project Management
Regulatory Approval for
Revenue Generation
Supporting your goal of gaining access to
revenue generating markets
Project Phases
Free Discovery Call
∙ Learn about existing approvals
∙ Learn about clients target markets
Gap Analyse
∙ Define classification
∙ Identify gaps in product files
∙ Present Effort & Time Estimate to client
Project Execution & Handover
∙ Onboarding of consultants
∙ Project execution
∙ Knowledge transfer & handover
Case Studies
MDR Compliance Project - Design Control, Risk Management, Substances, UDI. On time & On Budget
Customer Facing Documentation
EU MDR Compliance - Gap Assessment support
Drug product primary packaging
Full MDR update of Technical documentation and QMS including Clinical, PMS, Substances, Risk Management. On Time & ON Budget
A small to medium size medical device company which sell Class I medical devices in the US and Europe (100-500 SKUs) require EU MDR compliance for their devices to continue selling in the European market. An EU authorized representative is already defined; however, several updates are required to the existing procedures (QMS) and product documentation (Tech File) in order to meet the new EU MDR requirements. Swiss MPC resourced the project, updated and created new documents such as Clinical Evaluation, Risk Management and Post Market Surveillance to name a few. In addition, all IFUs and labels were updated to comply with MDR and UDI requirements. Swiss MPC managed the interface with the EU authorized representative until approval was granted.
Timeline 4-6 months
A global pharmaceutical company required technical support with second sourcing drug primary packaging components as well as medical devices which are intended to be used with a drug product (combination product). This involved a landscape evaluation of the market, the acquisition of samples, lab testing, machinability testing and ultimately official technical and DHF documentation to support the newly introduced components with existing drug products.
Timeline 24-36 months
A global orthopedic company specializing in implants and instruments (Class IIa and Class III) required DHF updates to remediate legacy and new systems to comply with new global regulations. Swiss MPC supported determining manufacturing adjuvants and their impact on biocompatibility as well as IFU and Labelling changes. In addition, many DHF documents were reviewed or updated.
Timeline 12-15 months
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