Medical Devices | ISO 13485

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ISO 13485 Transition Consulting

ISO 13485 Transition Consulting provided by JJK team, shields you from any missteps while getting your ISO certification approved.

Medical Devices

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 QSR

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 regulation 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

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) replaced by 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 revised the 13845 standard in 2016. 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

 

MDD 93/42/EEC CHANGES to MEDICAL DEVICE REGULATIONS (MDR)

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.

NEW MDR EU REGULATIONS

The most important changes at a glance

Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) regulations in many areas are creating higher or new business and monitoring requirements. For example, the higher classification u. a. software, material medical devices and reusable surgical invasive instruments and products containing nanomaterials.

Risk class I introduces the subgroup Ir (“R” for reusable) for reusable surgical instruments. Furthermore, the demands on the quality management system and the technical documentation as well as new regulations fo post-market surveillance are new challenges for medical device production companies.

The clinical evaluation requirements have increased, along with the much more difficult, in the opinion of experts now almost impractical reference to the clinical data of a similar product (equivalence analysis). There are also major changes for the cooperation between Original Equipment Manufacturer (OEM) and the Private Label Manufacturer (PLM).

For class IIb active products that deliver or deliver drugs to the body and class III implants, a clinical trial consultation procedure is introduced (“Scrutiny Procedure”).

In addition, the introduction of Unique Device Identification (UDI) will result in new labeling requirements for the EU, like in the U.S.A. The introduction of UDI labeling is introduced with the goal of better traceability of the products, graduated in time by class.

In future, medical device manufacturers will be required to store data about themselves, their products and information about the UDIs in the EU managed EUDAMED database. However, this is still in the implementation phase and should be made available on March 26, 2020, two months before the final date of MDR application.

Introduction of the “Representative”: Each manufacturer must name at least one such person internally. Their tasks goes beyond those of the safety officer, as well as the requirements for qualification and experience. For companies with fewer than 50 employees, there is the exception, under certain circumstances, that the responsible person can also be nominated externally.

In addition, a completely new classification system results for in vitro diagnostics – from a list-based system to a system with the four risk classes A-D. There is also a reduction to three possible conformity assessment procedures. In future, every manufacturer of an IVD must have a quality management system.

Along with the increased demands, many medical device products are now under the supervision of a Notified Body for the first time (e.g., class Ir products, more highly classified products, many in vitro diagnostic medical devices).

The detailed transitional provisions can be found in the regulation texts see here.

 

JJK Consulting MDR Expert Team

Companies are therefore well advised to study the regulations in depth, to evaluate what this entails for their company, for new and existing products on the market, to evaluate status of re-accreditation with their existing Notified Bodies, to provide training and information to employees, and to tackle the implementation of the new requirements. By tightening European regulations for medical devices, there will be a significant extra effort, especially for small and medium-sized companies in the healthcare industry.

JJK Consulting has created a MDR expert team for our client’s in regarding to the new MDR regulation changes. The expert team can answer all questions around the new EU MDR regulations.
For more information, please contact us here.

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.