ISO 13485 Transition Consulting
ISO 13485 Transition Consulting provided by JJK team, shields you from any missteps while getting your certification approved.
Medical Device certification requirements can be a bottleneck in getting new or improved products to market. Regulatory missteps in launching new medical devices can cost companies thousands or even millions of dollars in lost sales.
Companies that can successfully navigate the regulation requirements for medical devices and launch a new standards-compliant product have a real market advantage.
Medical Device Definition
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article, which medical professionals use to diagnose, prevent or treat disease or other conditions. A medical device does not achieve its purposes through chemical action within or on the body, which would make it a drug.
Medical Device Services
If you want to market your medical device to a global market, you must establish a compliant quality management system.
We are experts in guiding clients through the complexities of medical device regulations. We do not take a quick fix approach. We do more than help clients obtain their desired certification. Our team is committed to adding real value to each client’s bottom line.
We are also committed to clients for the long-haul. Companies must nurture their quality management system to maintain the system’s effectiveness. We help clients with ongoing support services. With this ongoing support, clients minimize their risk of triggering a costly re-audit.
Our consultants have guided countless companies to successful certification in the following standards and regulations.
FDA 21 CFR Part 820 governs the methods organizations use to design, manufacture, package, label, store, install and serve all finished devices for human use.
Under this regulation manufacturers, specification developers, contract manufacturers, re-labelers and re-processors must develop a quality regulations system (QSR). This regulation does not define the specifics of the QSRs. It details the requirements covered entities must follow in establishing their QSRs.
FDA QSR Consulting Services
Our consulting team has worked with global Fortune 500 companies and small start-up manufacturers. We can assist clients in range of QSR services from helping clients establish design controls through conducting audits. We will scale our consulting efforts to match the needs of each client’s products and culture.
Our consulting services can include:
- Design control procedures, implementation and audits
- Design development plan
- DMR (device master record)
- Risk management program development, and analysis
- Medical Device product design history file compliance
- Biocompatibility and sterilization assessment
- Medical device standards assessment
- Process validation (IQ/OQ/PQ)
- Change control
ISO 13485:2003 (CMDCAS) and ISO 13485:2016
The ISO 13485 standard covers the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The ISO has currently revising the 13845 standard. The working title of the next revision is now ISO 13485:2016. JJK is providing ISO 13485 Transition Consulting to help you get certified.
ISO 13485 Services
Our ISO 13485 transition consulting team can make sure that the QMS for your medical device initiatives comply with the current standards. We can also help you understand the expected standard revisions and make sure your system can easily adapt to the new version. We work with clients in Europe, the US and Canada and can consult on CMDCAS.
With our services, we can help you:
- Establish your ISO 13485-compliant quality management system criteria
- Conduct a GAP Analysis
- Identify deficiencies and recommend corrective actions
- Establish your business processes
- Define your training requirements
- Implement your quality management system
- Develop your record reporting procedures
- Conduct pre-audit assessment
- Manage the certification process
The European Commission (EC) published the Medical Device Directive in 1993. Entities can only sell medical devices in Europe that carry the EC’s CE Mark. With this mark, manufacturers declare that the device meets the applicable EC standards.
To place a CE mark on a device, the European Community requires that manufacturers comply with one of three special directives: Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD) or the Active Implantable Medical Device Directive (AIMDD).
Without the CE Mark you cannot sell your medical device within the European Community.
CE Mark Services
Our experienced consultants will guide you in obtaining the appropriate CE Mark. We can help you:
- Determine the relevant EU classification for your device
- Prepare your technical file
- Prepare your audit application
- Work through the audit process
- Identify a responsible person (a EU-based CE Mark representative for your company)
Our experts in medical devices can assist your team in all aspects of compliance, regulation and standards.
For a no-obligation proposal regarding ISO 13485 transition consulting services, please contact us.