Services: Regulatory Affairs-Device

For Medical Device Industry

DHF Design History File Remediation

Background

regulatory complianceA Notified Body warned a large medical device company that their ISO certification would be withdrawn unless serious inadequacies in the design history file (DHF) were addressed. ISO certification withdrawal would mean that the CE Mark could no longer be applied to product labeling, and the products could no longer be sold in countries where the CE Mark is required. An internal gap analysis suggested a technical file remediation strategy was missing. 

Challenge

Regulatory Compliance Associates® was contracted to provide program oversight as well as teams of resources, spread across several design centers and manufacturing sites. The objective was to coordinate the required design history file remediation activities. Due to the extent of remediation needed, a phased, risk-based implementation strategy was used to ensure efficient progress in accordance with budget limitations.

Approach

RCA led and resourced DHF remediation team in the following areas:

  • Customer Requirements
  • Risk Management – Use, Design, and Process
  • Sterilization Validation
  • Design Validation Testing
  • Essential Requirements Checklist
  • Product Specifications
  • Design Verification Testing
  • Shelf Life Testing – Product and Package
  • Process Validation
  • Remediation included gap analyses, development and execution of test protocols, risk analyses, and updating of documentation as required to support the technical files for each product family.

Result

Design history files for each product family were updated as comprehensive testing and DHF documentation was completed. The Notified Body was satisfied with the program progress and the quality of remediation accomplished, and withdrawal of ISO certification was avoided.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Medical Device Validation: Shelf Stability

Background

regulatory complianceA large medical device manufacturer was developing a new product to collect blood samples. Accelerated shelf age validation testing found that the protective sheath surrounding the needle in the device did not have adequate reseal characteristics. After aging, the sheath was not reliable in preventing leakage of the blood samples after needle puncture. Shelf stability became an immediate concern that could no longer go unaddressed. 

Challenge

The reseal failures came as a surprise since unaged test samples had not experienced failures. This led the program to fall behind schedule, and quickly finding a workable solution was considered critical to the success of the new product development.

What is Shelf Stability?

Shelf stability is a combination of the time it takes for your product to be unfit for use or consumption. It is tested by using artificial aging scenarios where changing the environment can help to predict the lifespan of a product. Additionally, real time aging studies can help provide data on how a product changed when packaging is exposed to different types of storage conditions. 

Approach

RCA’s medical device compliance team recognized that ISO 11607 requires a shelf life validation study to be conducted by a sterile medical device manufacturer. Further, shelf stability and packaging strategy must be examined when temperature and humidity levels are simulated to be higher than the norm. 

The material of construction to be tested was synthetic polyisoprene. Additionally, different experiments were conducted employing alternative synthetic polyisoprene formulations, but to achieve the proper reseal, it was necessary to change the material to natural polyisoprene (natural rubber latex).

Result

Design verification and validation testing was completed, and design review and design transfer were conducted. The design history file was updated, and ultimately the product was successfully launched employing the natural rubber latex sleeves. Shelf stability was immediately improved due to the proper reseal. 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Brand Name Re-Registration with New Logo

Background

A medical device manufacturer was consolidating its product portfolio, leading to a product and logo change in 15 products distributed across 60 countries. Since the company name and the manufacturing address remained unchanged, the manufacturer was unclear on the registration requirements. A brand name re-registration and logo update needed to be updated and submitted regionally. 

Solution

On a country-by-country basis, Regulatory Compliance Associates® Inc. developed the registration and customs requirements and executed the go-forward plan. In some countries, re-registration was required and RCA handled the submission.

In many countries, the bigger hurdle was ensuring the newly labeled product would pass customs requirements. RCA communicated the new brand name re-registration to the local Ministries of Health and the labeling change to distributors in each country.

Results

The manufacturer was able to change the product label and not interrupt any product sales. The brand name re-registration was approved and regulatory action has not been needed since the project ended. 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

CE Mark: Clinical Evaluation

Background

Devicor, the leading breast biopsy device manufacturer, wanted an updated CE mark strategy to expand distribution with new products and provide continuity with legacy products obtained through a divestiture. The Medical Device Directive requires a clinical evaluation to verify medical device clinical safety and performance.

Solution

Devicor engaged Regulatory Compliance Associates to build a clinical evaluation process to achieve CE Mark approval. RCA identified clinical data by conducting literature searches based on key words and phrases, filtered through studies and data for relevant information and developed abstracts for incorporation with Devicor’s final submission.

Results

Besides crafting the plan, RCA was instrumental in data collection and analysis of clinical data, reviewing thousands of papers. This expertise helped Devicor complete the submission, leading to the CE Mark registration and enabling continuity of existing products and expanded distribution of new product. Based on this successful experience, Devicor will gladly look to RCA for future needs in clinical evaluations.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.